Clinical Scientist

Sanofi•Cambridge, MA

1d•Hybrid

About The Position

This role is key to supporting the medical supervision of clinical studies by Clinical Research Directors (CRD) and ensuring scientific management of clinical studies performed by the Clinical & Sciences Operations Platform (CSO) and Development Units. The primary purpose of the Clinical Scientist's position is to assist/support the CRD and the study team in the medical/scientific contribution for clinical studies, including supporting operational activities pertaining to protocol development, validation and clinical case review of study data, review of study plans and reports, medical/scientific information search, literature review and analysis, and assistance in preparing responses for investigators, study teams, ethics committees or regulatory authorities. The scope includes all clinical trials for projects in development. This position is specifically aimed to support Inflammation and Immunology development.

Requirements

Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field
1-2 years of clinical development experience in pharmaceutical/biotech industry preferred
Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
Understanding of clinical trial processes and adverse event reporting
Scientific expertise or interest and ability to learn in the domain of assigned study/project
High level of autonomy and motivation
Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
Able to develop good quality management practices using data-driven and risk management approach
Quality focused and well organized
Strong attention to detail and accuracy in clinical documentation and data review
Ability to handle multiple tasks and to prioritize
Ability to synthesize information, good presentation skills
Excellent decision-making and problem-solving capabilities
Capability to challenge decisions and status quo
Ability to work autonomously and efficiently provide status reports
Ability to anticipate and timely escalate issues and define appropriate action plans
Team and results oriented
Teaching skills, ability to assist and train others
Strong scientific writing and communication skills
Strong English skills (verbal and written)
Ability to work effectively in cross-functional, matrix environment

Nice To Haves

Experience in Immunology/Inflammation therapeutic area
Clinical trial experience across multiple phases (Phase I-III)
Experience with clinical data management systems and eCRF platforms
Familiarity with medical terminology and disease pathophysiology

Responsibilities

Ensure scientific support for operational realization for assigned study/studies or registries by securing the operationalization of the medical validation/review plan (reports and trackers)
Contribute to preparation and/or review of documents requiring scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, trial disclosure forms)
Participate in Study Team and monitoring team training on medical information
Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments
Help rationalize and document data collection needs quantitatively and qualitatively
Contribute to definition of centralized monitoring strategy in consistency with planned statistical analysis
Support study data validation and review processes
Assist CRD for Clinical Case review (safety events reported to GPE or safety events of special interest)
Review and assess adverse events and protocol deviations
Assist in preparation of safety reports and regulatory submissions
Communicate effectively with CRD and study team on potential safety signals or study risks
Help with preparation, organization, conduct and minutes of Study Committees
Follow contracts with business support
Provide or prepare medical/scientific information/documentation/analysis for protocol preparation or study conduct
Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings
Support regulatory documents filing and archiving
Work closely with the Clinical Research Director (CRD) to implement study strategies and protocols
Under guidance of CRD, collaborate with Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers (GSMs and RSMs), Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) as needed
Support CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with Clinical Trial Team (Monitoring Teams) or Pharmacovigilance
Collaborate with study team members to ensure alignment on study objectives and timelines
Participate in regular study team meetings to provide clinical input and updates
Partner with study team members to ensure data quality and integrity
Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
Develop good quality management practices, including guidelines, regarding medical data review activities using data-driven and risk management approach
Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
Assess and provide cost elements related to study support in collaboration with study team, including GPPM
Promote, track, and accompany usage of electronic reporting solutions in context of medical review/validation