Clinical Scientist

Job Title: Clinical Scientist

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Clinical Scientist is a key member of Medical Team with responsibilities to provide scientific support for late-stage clinical studies. The role requires close collaboration with Clinical Research Director (CRD) alongside other Study Team members : the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance. The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary …).

• Supports CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project

• Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan

• Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity

• Develops study specific training material and participates to the Investigators, Study Team, and monitoring team training on medical information

• Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to GPV or safety events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.

• Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings

• Supports to regulatory documents filing and archiving

• Review of study plans, study reports, publications for accuracy with clinical study report as well as ensuring completeness of study reports appendices under the responsibility of the CRD.

About You

Essential requirements:

• Scientific expertise or interest and ability to learn in the domain of assigned study/project.

• Leadership to give directions and organize the activities on behalf of the CRD

• Quality focused, able to develop good practices, using a critical data-driven and risk management approach

• Familiar with digital tools such as data analytics or agility to use them

• Multiple tasks handling and prioritization with the ability to work autonomously and to efficiently provide status reports and to anticipate and timely escalate issues and to execute action plans

• Ability to synthesize the information, good presentation skills and effective communication skills (verbal and written)

• Team and results oriented

• Experience of workin