Sanofi Group Senior Clinical Scientist in Bridgewater, New Jersey
This role is key to help the medical supervision of clinical studies by Clinical Study Directors and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) of Sanofi R&D.
The primary purpose of the Senior Clinical Scientist (SCSc) position is to assist/support the Clinical Study Director (CSD) in the medical/scientific contribution for the clinical studies. e.g: contributing/reviewing of extended synopsis, protocols, amendments, amended protocols, support to medical review of study data (especially safety data with reconciliation), review of draft study reports or draft publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, helps manage study committees.
Scope include all clinical trials for projects in development (excluding Phase I in healthy subjects, Phase I onco and POC managed by CEP) and clinical studies (e.g. registries) for marketed drugs or devices, from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD …).
Under the guidance of the CSD and/or OMD&CD management : he/she collaborates with the Coding specialist, Biostatisticians, CTOMs, R-TMs, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. review of narratives) on high quality medical review, as needed. He/she supports the Head Clinical Scientists, Medical Coding & Review, and functionally the CSD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
To better serve the activity, and depending on his/her experience, a Senior Clinical Scientist can be dedicated to a specific task for a certain period of time, following business needs.
Ensure scientific support for operational realization within the CSO for study(ies) or registries he/she is allocated to, under the functional supervision of the CSD and/or OMD&CD management, by securing the operationalization of the medical validation/review plan (reports and trackers).
Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of decreasing the complexity.
For all new protocols, is in charge of calculating the protocol complexity index, before and after protocol review, and after any protocol amendment.
Is involved in some of the medical reviews of study data under the CSD supervision, support the CSD for the medical review of data with the manual reconciliation of the case by case review of safety events reported to GPE or safety events of special interest, listings.
Help for the preparation, organization and minutes of study Committees, follow the contracts with business support.
Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (extended synopsis, protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form…). Participates to the CTT and monitoring team training on medical information.
Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct.
Support CSD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project.
Support CSD in organizing Steering committees, Data Monitoring Committees, Adjudication Committee meetings.
Develop good quality management practices, including guidelines, as regard to medical review/validation activities.
Support to regulatory documents filing and archiving.
In collaboration with study team, including IPOM, is in charge of designing, providing cost elements related to the study design.
Promote and develop use of electronic tools (J review, e-PP) in the context of medical review/validation.
Develop study specific training material for training to Medical advisors and sites.
Propose and develop in coordination with CSD and CTOM/DM study specific medical data points checks based on protocol efficacy criteria.
CTOM track and follow-up on missing data related to these criteria.
With CSD, define precisely the critical data, and implement/develop related sections of the study risk management plan.
Coordinate medical validation/review activity with CME and GSO from GPE, notably to anticipate and prevent last minute queries or backlog, and smoothen the process.
MD, Ph.D., Pharm.D., or similar; bachelor’s degree considered for candidates with experience.
Previous experience in Clinical Research and/or Drug Development (e.g., at least 5 years within pharma industry or CRO).
Preferred Knowledge and Skills:
Scientific expertise or interest and ability to learn in the domain of assigned study/project.
High level of autonomy and motivation
Quality focused and well organized
Strong communication skills (verbal and written)
Ability to handle multiple tasks and to prioritize
Ability to synthesize the information, good presentation skills
Excellent decision-making and problem-solving capabilities
Capability to challenge decision and status quo
Ability to work autonomously and to efficiently & effectively provide status reports
Ability to anticipate and timely escalate issues and to define appropriate action plans
Team and results oriented
Teaching skills, ability to assist and train others
Strong English skills (verbal and written if English is the second language)
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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