Senior Clinical Scientist / Project Manager III with Sanofi

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POST DATE 8/9/2016
END DATE 12/19/2016

Sanofi Bridgewater, NJ

Company
Sanofi
Location
Bridgewater, NJ
AJE Ref #
575828393
Job Classification
Full Time
Job Type
Regular
Company Ref #
28654030

JOB DESCRIPTION

Job Title: Senior Clinical Scientist

Location : Bridgewater . NJ

Sr. CLINICAL SCIENTIST

JOB PURPOSE

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 Clinical Scientist's (CSc) 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 medical operations 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 Leader, Transversal Functions and functionally to 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.

KEY INDIVIDUAL ACCOUNTABILITIES
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 Medical Operations 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 UMO, is in charge of designing, providing cost
elements related to the study design.
Promote and develop use of electronic tools (A/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.
With 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.

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 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).
Knowledge in ICH, GCP. Fluent in English.