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Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Data Scientist/Data Manager who shares our vision of providing clinical research excellence.

Joining Pivotal as a Clinical Data Scientist/Data Manager, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

 You will oversee data management and clinical surveillance activities, including:

• Support the design and management of CRFs and the study database (DB), including design, setup, validation, data entry oversight and training.
• Developing and maintaining the Data Management Plan, Data Quality Plan, and Edit check specifications.
• Creating CRF guidelines, annotated CRFs, and managing data discrepancies.
• Providing analytical support for clinical trial data, including analysis, interpretation, and preliminary recommendations.
• Monitoring data review issues, ensuring timely query resolution, and performing QA/QC for the study database.
• Managing database lock processes and applying a risk-based approach to assess trials and proactively address issues.
• Communicating data review findings to internal and external stakeholders.
• Supporting study committee activities (e.g., DMC).
• Maintaining the DMBS file system.
• Identifying, monitoring, and tracking potential study risks.
• Assisting in the development of predictive models, machine learning algorithms, and visualization techniques to identify trends and propose solutions in collaboration with data architects, software engineers, and product development teams.
• Performing other assigned duties as needed.

Required profile:

• University degree highly recommended
• 4 years in Data Management Systems at a CRO or pharmaceutical company.
• Hands-on experience with CDM systems: Medidata Rave Zelta, Medrio, Oracle u others.
• Familiarity with GCDMP, ICH and CDISC standards (specially CDASH) and applicable data privacy regulations.

Skills:

• Strong critical thinking, problem-solving, and organizational skills.
• Proficiency in MS Office and data analysis tools.
• Fluency in English (spoken and written).
• Effective communication, empathy, and teamwork abilities.

What You Can Expect:

• Career growth resources and flexible work schedules.
• Training to enhance therapeutic knowledge.
• Exposure to dynamic work environments and new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Programmer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Clinical Programmer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

 Serve as the clinical database programmer for the design, validation, and implementation of clinical data management systems (e.g., EDC, eCOA, eConsent, Epro, RTSM).

• Collaborate on efficient database implementation for clinical studies.
• Identify and develop tools and process improvements to enhance team, project and business efficiencies.
• Provide programming support for data management activities, including database development and data validations.
• Collaborate with multi-disciplinary teams to meet project deadlines and budgets.
• Ensure compliance with SOPs, CDISC/CDASH standards, ICH, EMEA, FDA, GDPR and other regulatory requirements.
• Design, build, test, and update project databases, edit checks, and listings for data review.
• Perform post-production database updates and validations.
• Integrate external data in the CDMS
• Document work, manage tasks to meet timelines, and deliver high-quality results.
• Support study teams and communicate progress on assigned tasks.
• Attend study team meetings during study setup to ensure alignment and accuracy.
• Continuously develop knowledge in programming, technology, and clinical processes.
• Perform additional related duties as required

Required profile:

• University degree highly recommended.
• At least 1 year in Data Management Systems at a CRO or pharmaceutical company.
• Proficiency in one or more programming languages and relational CDMS (e.g. (Medidata Rave, Zelta, Medrio, Oracle, u others).
• Formal accreditation in database administration and programming is highly desirable

Skills:

• Strong problem-solving skills, attention to detail, and ability to work under pressure.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills in English.
• Team player with strong interpersonal and organizational skills

What you can expect:

• Career growth resources and flexible work schedules.
• Training to enhance therapeutic knowledge.
• Exposure to dynamic work environments and new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Junior SDTM Programmer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Junior SDTM Programmer who, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal:

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

The ideal candidate will specialize in the creation and validation of Study Data Tabulation Model (SDTM) datasets to ensure regulatory compliance for clinical trials. A strong command of R programming, coupled with familiarity with CDISC standards, is required for this role.

• Develop and validate SDTM datasets to meet CDISC standards and regulatory requirements (FDA, EMA).
• Collaborate with clinical data managers, statisticians, and study team members to ensure accurate data transformation and standardization.
• Write and validate R scripts for data analysis, cleaning, and mapping to SDTM datasets.
• Review case report forms (CRFs) and annotated CRFs to ensure compatibility with SDTM requirements.
• Generate SDTM domains, including custom domains when needed, and ensure dataset readiness for submission.
• Conduct quality control (QC) of SDTM datasets and associated documentation.
• Produce Define.xml and metadata files to support SDTM datasets.
• Automate processes for dataset generation and validation using R.
• Stay updated on CDISC guidelines, regulatory changes, and R programming advancements.

Required profile:

• Bachelor’s or Master’s degree in Computer Science, Biostatistics, Life Sciences, or a related field.
• Experience in R programming with a focus on data wrangling, validation, and statistical analysis.
• Experience with clinical data programming tools (e.g., SAS, Python, RStudio or VSCode).
• Ability to understand xml and json files.
• Familiarity with database structures.
• Experience with Git for version control.
• Familiarity with reporting and data visualization using R libraries (e.g., ggplot2, shiny).

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment
• Ability to work autonomously
• Fluent in English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Lead/Senior Safety Officer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Lead/Senior Safety Officer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

We are passionate and fully committed with medical science while using technology, to make a positive impact

We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life

We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Description:

Lead/Senior Safety Officer will give safety support for the projects with pharmacovigilance activities in order to meet the clients‘ needs and build new business for Pivotal. Support to clinical projects will ensure successful and timely completion of each project or study in accordance with Pivotal and/or sponsor´s SOPs, GCPs and national/international regulations.

Lead/Senior Safety Officer will support:

• Development, tracking, reporting, and enhancing of the activities related to pharmacovigilance in clinical studies.
• Maintenance of pharmacovigilance systems, including the safety database (ARGUS).
• Data entry, review, and assessment of safety reports reports (including narrative writing) from clinical trial and post-marketing sources onto the safety database (ARGUS), in accordance with company SOPs and regulatory requirements.
• MedDRA coding, including study coding reviews.
• Preparation and submission of expedited reports to the regulatory authorities, including reporting to EudraVigilance, and periodic safety reporting to the regulatory authorities (e.g., IRAS and CTIS)
• Safety events reconciliations.
• Performing periodic quality controls of the safety database.
• Creation and review of periodic safety reports such as DSURs and any other regulatory document as required.

Required profile:

• University Science Degree (preferably life sciences or related) is advisable.
• Between 5-7 years of Pharmaceutical Industry experience within Safety department is recommended.
• Sound knowledge of GCPs/ICH and Spanish and International Regulations.
• Intermediate level of spoken and written English.
• Good knowledge of current PC-applications.
• Highly committed and ability to work under pressure.
• Team player and good communications skills.
• Empathy and ability to establish good relationships with others.

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast- pace environment
• Ability to work autonomously
• Ability to work in multiple projects
• Fluency in English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior/Principal Biostatistician who shares our vision of providing clinical research excellence.

Joining Pivotal as a Senior/Principal Biostatistician means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

This position is responsible for leading the biostatistics component of projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Provides external statistical consultancy for sponsor companies and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

• Work as the assigned statistician on multiple studies or program studies, independently or as the lead statistician as required.
• Coordinate the activities of other biostatistics/programming personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians/statistical programmers in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
• May lead complex or multiple projects and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs, ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Requirements:

• Graduate degree in biostatistics, maths or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
• Proficiency in SAS programming and any other language (R; WinNonlin or similar).
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Knowledge and prior experience in handling CDISC standards (SDTM/ADaM files) and preparing final documentation for submission.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Experience in interacting with regulatory agencies, as well as in regulatory submissions, is valued.
• Prior experience with Bayesian methods and pharmacokinetic/pharmacodynamic statistical analysis will be highly regarded
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.

Joining Pivotal as a CRA/SCRA means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

• Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies
• Perform site selection, initiation, monitoring and close-out visits
• Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations
• Evaluate the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and local regulations. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Manage site progress by tracking recruitment, eCRF completion, and data query resolution
• Participate in problem-solving and risk-mitigation strategies
• Collaborate with experts at study sites and with client representatives
• Maintain a working knowledge of relevant regulations and company SOPs/processes
• Demonstrate diligence in protecting the confidentiality of each subject/patient
• Maintain study files in collaboration with our CTAs and eTMF specialists.

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training and experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Flexibility to travel 6-8 visits per month

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-pace environment
• Ability to work autonomously
• Fluency in Italian and English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.

Joining Pivotal as a CRA/SCRA means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

• Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies
• Perform site selection, initiation, monitoring and close-out visits
• Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations
• Evaluate the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and local regulations. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Manage site progress by tracking recruitment, eCRF completion, and data query resolution
• Participate in problem-solving and risk-mitigation strategies
• Collaborate with experts at study sites and with client representatives
• Maintain a working knowledge of relevant regulations and company SOPs/processes
• Demonstrate diligence in protecting the confidentiality of each subject/patient
• Maintain study files in collaboration with our CTAs and eTMF specialists.

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training and experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Flexibility to travel 6-8 visits per month
• Experience in CNS is required.

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-pace environment
• Ability to work autonomously
• Fluency in German and English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.

Joining Pivotal as a CRA/SCRA means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

• Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies
• Perform site selection, initiation, monitoring and close-out visits
• Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations
• Evaluate the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and local regulations. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Manage site progress by tracking recruitment, eCRF completion, and data query resolution
• Participate in problem-solving and risk-mitigation strategies
• Collaborate with experts at study sites and with client representatives
• Maintain a working knowledge of relevant regulations and company SOPs/processes
• Demonstrate diligence in protecting the confidentiality of each subject/patient
• Maintain study files in collaboration with our CTAs and eTMF specialists.

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training and experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Flexibility to travel 6-8 visits per month

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-pace environment
• Ability to work autonomously
• Fluency in Italian and English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.

Joining Pivotal as a CRA/SCRA means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

• Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies
• Perform site selection, initiation, monitoring and close-out visits
• Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations
• Evaluate the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and local regulations. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Manage site progress by tracking recruitment, eCRF completion, and data query resolution
• Participate in problem-solving and risk-mitigation strategies
• Collaborate with experts at study sites and with client representatives
• Maintain a working knowledge of relevant regulations and company SOPs/processes
• Demonstrate diligence in protecting the confidentiality of each subject/patient
• Maintain study files in collaboration with our CTAs and eTMF specialists.

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training and experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Flexibility to travel 6-8 visits per month
• Experience in CNS is required.

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-pace environment
• Ability to work autonomously
• Fluency in German and English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Data Scientist/Data Manager who shares our vision of providing clinical research excellence.

Joining Pivotal as a Clinical Data Scientist/Data Manager, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

 You will oversee data management and clinical surveillance activities, including:

• Support the design and management of CRFs and the study database (DB), including design, setup, validation, data entry oversight and training.
• Developing and maintaining the Data Management Plan, Data Quality Plan, and Edit check specifications.
• Creating CRF guidelines, annotated CRFs, and managing data discrepancies.
• Providing analytical support for clinical trial data, including analysis, interpretation, and preliminary recommendations.
• Monitoring data review issues, ensuring timely query resolution, and performing QA/QC for the study database.
• Managing database lock processes and applying a risk-based approach to assess trials and proactively address issues.
• Communicating data review findings to internal and external stakeholders.
• Supporting study committee activities (e.g., DMC).
• Maintaining the DMBS file system.
• Identifying, monitoring, and tracking potential study risks.
• Assisting in the development of predictive models, machine learning algorithms, and visualization techniques to identify trends and propose solutions in collaboration with data architects, software engineers, and product development teams.
• Performing other assigned duties as needed.

Required profile:

• University degree highly recommended
• 4 years in Data Management Systems at a CRO or pharmaceutical company.
• Hands-on experience with CDM systems: Medidata Rave Zelta, Medrio, Oracle u others.
• Familiarity with GCDMP, ICH and CDISC standards (specially CDASH) and applicable data privacy regulations.

Skills:

• Strong critical thinking, problem-solving, and organizational skills.
• Proficiency in MS Office and data analysis tools.
• Fluency in English (spoken and written).
• Effective communication, empathy, and teamwork abilities.

What You Can Expect:

• Career growth resources and flexible work schedules.
• Training to enhance therapeutic knowledge.
• Exposure to dynamic work environments and new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Programmer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Clinical Programmer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

 Serve as the clinical database programmer for the design, validation, and implementation of clinical data management systems (e.g., EDC, eCOA, eConsent, Epro, RTSM).

• Collaborate on efficient database implementation for clinical studies.
• Identify and develop tools and process improvements to enhance team, project and business efficiencies.
• Provide programming support for data management activities, including database development and data validations.
• Collaborate with multi-disciplinary teams to meet project deadlines and budgets.
• Ensure compliance with SOPs, CDISC/CDASH standards, ICH, EMEA, FDA, GDPR and other regulatory requirements.
• Design, build, test, and update project databases, edit checks, and listings for data review.
• Perform post-production database updates and validations.
• Integrate external data in the CDMS
• Document work, manage tasks to meet timelines, and deliver high-quality results.
• Support study teams and communicate progress on assigned tasks.
• Attend study team meetings during study setup to ensure alignment and accuracy.
• Continuously develop knowledge in programming, technology, and clinical processes.
• Perform additional related duties as required

Required profile:

• University degree highly recommended.
• At least 1 year in Data Management Systems at a CRO or pharmaceutical company.
• Proficiency in one or more programming languages and relational CDMS (e.g. (Medidata Rave, Zelta, Medrio, Oracle, u others).
• Formal accreditation in database administration and programming is highly desirable

Skills:

• Strong problem-solving skills, attention to detail, and ability to work under pressure.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills in English.
• Team player with strong interpersonal and organizational skills

What you can expect:

• Career growth resources and flexible work schedules.
• Training to enhance therapeutic knowledge.
• Exposure to dynamic work environments and new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Junior SDTM Programmer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Junior SDTM Programmer who, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal:

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

The ideal candidate will specialize in the creation and validation of Study Data Tabulation Model (SDTM) datasets to ensure regulatory compliance for clinical trials. A strong command of R programming, coupled with familiarity with CDISC standards, is required for this role.

• Develop and validate SDTM datasets to meet CDISC standards and regulatory requirements (FDA, EMA).
• Collaborate with clinical data managers, statisticians, and study team members to ensure accurate data transformation and standardization.
• Write and validate R scripts for data analysis, cleaning, and mapping to SDTM datasets.
• Review case report forms (CRFs) and annotated CRFs to ensure compatibility with SDTM requirements.
• Generate SDTM domains, including custom domains when needed, and ensure dataset readiness for submission.
• Conduct quality control (QC) of SDTM datasets and associated documentation.
• Produce Define.xml and metadata files to support SDTM datasets.
• Automate processes for dataset generation and validation using R.
• Stay updated on CDISC guidelines, regulatory changes, and R programming advancements.

Required profile:

• Bachelor’s or Master’s degree in Computer Science, Biostatistics, Life Sciences, or a related field.
• Experience in R programming with a focus on data wrangling, validation, and statistical analysis.
• Experience with clinical data programming tools (e.g., SAS, Python, RStudio or VSCode).
• Ability to understand xml and json files.
• Familiarity with database structures.
• Experience with Git for version control.
• Familiarity with reporting and data visualization using R libraries (e.g., ggplot2, shiny).

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment
• Ability to work autonomously
• Fluent in English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior/Principal Biostatistician who shares our vision of providing clinical research excellence.

Joining Pivotal as a Senior/Principal Biostatistician means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed with medical science while using technology, to make a positive impact
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

This position is responsible for leading the biostatistics component of projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Provides external statistical consultancy for sponsor companies and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

• Work as the assigned statistician on multiple studies or program studies, independently or as the lead statistician as required.
• Coordinate the activities of other biostatistics/programming personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians/statistical programmers in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
• May lead complex or multiple projects and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs, ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Requirements:

• Graduate degree in biostatistics, maths or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
• Proficiency in SAS programming and any other language (R; WinNonlin or similar).
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Knowledge and prior experience in handling CDISC standards (SDTM/ADaM files) and preparing final documentation for submission.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Experience in interacting with regulatory agencies, as well as in regulatory submissions, is valued.
• Prior experience with Bayesian methods and pharmacokinetic/pharmacodynamic statistical analysis will be highly regarded
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Lead/Senior Safety Officer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Lead/Senior Safety Officer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal: 

We are passionate and fully committed with medical science while using technology, to make a positive impact

We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life

We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Description:

Lead/Senior Safety Officer will give safety support for the projects with pharmacovigilance activities in order to meet the clients‘ needs and build new business for Pivotal. Support to clinical projects will ensure successful and timely completion of each project or study in accordance with Pivotal and/or sponsor´s SOPs, GCPs and national/international regulations.

Lead/Senior Safety Officer will support:

• Development, tracking, reporting, and enhancing of the activities related to pharmacovigilance in clinical studies.
• Maintenance of pharmacovigilance systems, including the safety database (ARGUS).
• Data entry, review, and assessment of safety reports reports (including narrative writing) from clinical trial and post-marketing sources onto the safety database (ARGUS), in accordance with company SOPs and regulatory requirements.
• MedDRA coding, including study coding reviews.
• Preparation and submission of expedited reports to the regulatory authorities, including reporting to EudraVigilance, and periodic safety reporting to the regulatory authorities (e.g., IRAS and CTIS)
• Safety events reconciliations.
• Performing periodic quality controls of the safety database.
• Creation and review of periodic safety reports such as DSURs and any other regulatory document as required.

Required profile:

• University Science Degree (preferably life sciences or related) is advisable.
• Between 5-7 years of Pharmaceutical Industry experience within Safety department is recommended.
• Sound knowledge of GCPs/ICH and Spanish and International Regulations.
• Intermediate level of spoken and written English.
• Good knowledge of current PC-applications.
• Highly committed and ability to work under pressure.
• Team player and good communications skills.
• Empathy and ability to establish good relationships with others.

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Strong written and verbal communication skills, attention to detail and ability to work in a fast- pace environment
• Ability to work autonomously
• Ability to work in multiple projects
• Fluency in English
• Good knowledge of Office (Word, Excel and PowerPoint)

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Trainings to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.