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

Joining Pivotal as a Regulatory Associate, 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:

• Provide strategic guidance related to regulatory requirements
• Ensure the timely execution of regulatory implementation activities, associated projects and documentation preparation for submission to ECs, CAs and any other applicable regulatory authority under the supervision of a regulatory coordinator
• Provide clear and timely communication of new and changing requirements
• Share local regulatory information with the team and integrate those requirements into Pivotal’s procedures
• Organize and maintain reporting schedules, trackers, and systems
• Review, prepare and negotiate contracts and budgets with sites and be the main point of contact with the sites during this negotiation process
• Develop and maintain relationships with CRAs contributing to the development and execution of local strategy (includes planning, prioritization, and preparation of responses to regulatory agencies’ questions and other correspondence)
• Support the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges, and process improvements throughout the program
• Support the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
• Develop and maintain constructive and cooperative working relationships with business functions in the organization
• Identify and facilitates continuous improvement activities
• Ensure compliance with applicable SOPs as required, quality and project timelines
• Distribute completed documents to sites and internal project team members
• Inform team members about study regulatory outcomes such as approvals
• May act as mentor, and prepare and deliver country-specific training, for less experienced staff

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of three years of Regulatory/star-up experience in clinical trials
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of European and/or country regulatory guidelines and regulations preferred
• Experience preparing regulatory submissions to ECs, CAs and any other applicable regulatory authority
• Specific experience in GMO medicinal products submission process
• Experience in contract and budget negotiations
• Experience in study leading activities across countries highly appreciated

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
• Programs to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

OVERVIEW

Pivotal is a leading one-stop shop offering CRO (Contract Research Organization) services to the healthcare industry. Our people are all bound by a shared passion for taking on the immense challenges of clinical development programs with Investigational Medicinal Products, medical devices, diagnostics and nutritional products. Pivotal’s leadership team contributes to managing growth and direction of the company and is highly committed to the company’s long-term goal and to foster Pivotal’s entrepreneurial culture.

Pivotal is looking for a Neurologist as MEDICAL MANAGER with around 4-5 years’ clinical experience to join our Medical Department.

PROFILE REQUIRED

We are looking for candidates with the following skills:

• Medical Degree and specialization in Neurology with at least 4-5 years’ clinical experience
• Management of global studies with medical/clinical report writing abilities at CRO or Pharmaceutical Company level is a plus
• Clinical development experience and/or solid clinical Neurology experience
• Fluent in English
• Good knowledge of Office (Word, Excel and PowerPoint)
• We value strong motivation, solid clinical experience, excellent communication skills and a team player attitude

APPLICATION PROCESS

If this sounds tempting, we are looking forward to receive your CV, together with details of academic achievements. Please send to isabel.joya@pivotalcr.com

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.

Overview:

Pivotal is a leading one-stop shop offering CRO (Contract Research Organization) services to the healthcare industry. Our people are all bound by a shared passion for taking on the immense challenges of clinical development programmes with Investigational Medicinal Products, medical devices, diagnostics and nutrition products. Pivotal’s leadership team contributes to managing growth and direction of the company and is highly committed to the company’s long-term goal and to foster Pivotal’s entrepreneurial culture.

We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth and we are currently employing nearly 200 cross-functional professionals in EU.

Proposal Analyst / Senior Analyst

We’re looking for a permanent Proposal Analyst / Senior Analyst role who will be responsible for:

• Support the proposals team throughout the full Request for Proposal and Bid Defense process with the creation and editing of all documents to be submitted (Excel files, Word documents and Power Point presentations).
• Support client contract processing.
• Participate in the proposals team meetings and activities as required.
• Overall coordination and accountability for the entire proposal preparation process, including coordination of all key operational areas ensuring timelines are met and deadlines are achieved for Phase I-Phase IV studies, consulting and other various types of services as provided by company.
• Provide review of client materials to disseminate information to the project team, senior management and sales leads. Works with Manager to identify information gaps and/or discrepancies, unique service requirements and translate information into proposal and budget
• Coordinate strategy meeting for proposal kickoff
• Prepares, edits and customizes proposal text to accurately reflect client needs and project teams strategic message. Ensuring all information is accurate and clearly stated including statistics, assumptions, processes described, etc.
• Work with Manager to communicate, review and negotiate with partners and vendors during the proposal development. Including provision of information, service and assumption requirements, timelines, budget metrics etc.
• Develop change orders for ongoing studies. Including budget development and justification for such need. Communication with client to support project team in the delivery of change orders and providing necessary information to support the adjustments needed
• Assists in the maintenance of departmental records and internal and intercompany reporting requirements including financial analysis of budgeted studies

Required Profile:

• 2 years of work experience is a plus.
• Analytical capabilities
• English written and verbal communication skills
• Strong organizational and time management skills including ability to quickly shift priorities
• Detail oriented, with a high focus on quality
• High proficiency in Excel and other Microsoft applications

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 Regulatory Associate who shares our vision of providing clinical research excellence.

Joining Pivotal as a Regulatory Associate, 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:

• Provide strategic guidance related to regulatory requirements
• Ensure the timely execution of regulatory implementation activities, associated projects and documentation preparation for submission to ECs, CAs and any other applicable regulatory authority under the supervision of a regulatory coordinator
• Provide clear and timely communication of new and changing requirements
• Share local regulatory information with the team and integrate those requirements into Pivotal’s procedures
• Organize and maintain reporting schedules, trackers, and systems
• Review, prepare and negotiate contracts and budgets with sites and be the main point of contact with the sites during this negotiation process
• Develop and maintain relationships with CRAs contributing to the development and execution of local strategy (includes planning, prioritization, and preparation of responses to regulatory agencies’ questions and other correspondence)
• Support the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges, and process improvements throughout the program
• Support the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
• Develop and maintain constructive and cooperative working relationships with business functions in the organization
• Identify and facilitates continuous improvement activities
• Ensure compliance with applicable SOPs as required, quality and project timelines
• Distribute completed documents to sites and internal project team members
• Inform team members about study regulatory outcomes such as approvals
• May act as mentor, and prepare and deliver country-specific training, for less experienced staff

Requirements:

• University Degree in life science or other scientific discipline or apprenticeship in health care
• Minimum of three years of Regulatory/star-up experience in clinical trials
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of European and/or country regulatory guidelines and regulations preferred
• Experience preparing regulatory submissions to ECs, CAs and any other applicable regulatory authority
• Specific experience in GMO medicinal products submission process
• Experience in contract and budget negotiations
• Experience in study leading activities across countries highly appreciated

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
• Programs to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences

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.

Overview:

Pivotal is a leading one-stop shop offering CRO (Contract Research Organization) services to the healthcare industry. Our people are all bound by a shared passion for taking on the immense challenges of clinical development programmes with Investigational Medicinal Products, medical devices, diagnostics and nutrition products. Pivotal’s leadership team contributes to managing growth and direction of the company and is highly committed to the company’s long-term goal and to foster Pivotal’s entrepreneurial culture.

We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth and we are currently employing nearly 200 cross-functional professionals in EU.

Proposal Analyst / Senior Analyst

We’re looking for a permanent Proposal Analyst / Senior Analyst role who will be responsible for:

• Support the proposals team throughout the full Request for Proposal and Bid Defense process with the creation and editing of all documents to be submitted (Excel files, Word documents and Power Point presentations).
• Support client contract processing.
• Participate in the proposals team meetings and activities as required.
• Overall coordination and accountability for the entire proposal preparation process, including coordination of all key operational areas ensuring timelines are met and deadlines are achieved for Phase I-Phase IV studies, consulting and other various types of services as provided by company.
• Provide review of client materials to disseminate information to the project team, senior management and sales leads. Works with Manager to identify information gaps and/or discrepancies, unique service requirements and translate information into proposal and budget
• Coordinate strategy meeting for proposal kickoff
• Prepares, edits and customizes proposal text to accurately reflect client needs and project teams strategic message. Ensuring all information is accurate and clearly stated including statistics, assumptions, processes described, etc.
• Work with Manager to communicate, review and negotiate with partners and vendors during the proposal development. Including provision of information, service and assumption requirements, timelines, budget metrics etc.
• Develop change orders for ongoing studies. Including budget development and justification for such need. Communication with client to support project team in the delivery of change orders and providing necessary information to support the adjustments needed
• Assists in the maintenance of departmental records and internal and intercompany reporting requirements including financial analysis of budgeted studies

Required Profile:

• 2 years of work experience is a plus.
• Analytical capabilities
• English written and verbal communication skills
• Strong organizational and time management skills including ability to quickly shift priorities
• Detail oriented, with a high focus on quality
• High proficiency in Excel and other Microsoft applications

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.

OVERVIEW

Pivotal is a leading one-stop shop offering CRO (Contract Research Organization) services to the healthcare industry. Our people are all bound by a shared passion for taking on the immense challenges of clinical development programs with Investigational Medicinal Products, medical devices, diagnostics and nutritional products. Pivotal’s leadership team contributes to managing growth and direction of the company and is highly committed to the company’s long-term goal and to foster Pivotal’s entrepreneurial culture.

Pivotal is looking for a Neurologist as MEDICAL MANAGER with around 4-5 years’ clinical experience to join our Medical Department.

PROFILE REQUIRED

We are looking for candidates with the following skills:

• Medical Degree and specialization in Neurology with at least 4-5 years’ clinical experience
• Management of global studies with medical/clinical report writing abilities at CRO or Pharmaceutical Company level is a plus
• Clinical development experience and/or solid clinical Neurology experience
• Fluent in English
• Good knowledge of Office (Word, Excel and PowerPoint)
• We value strong motivation, solid clinical experience, excellent communication skills and a team player attitude

APPLICATION PROCESS

If this sounds tempting, we are looking forward to receive your CV, together with details of academic achievements. Please send to isabel.joya@pivotalcr.com