Senior Clinical Project Manager
Location: Cambridge, Massachusetts, USA
GENFIT is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases, where there is still considerable unmet need.
The Senior Clinical Project Manager (CPM) will be responsible to provide clinical and operational expertise and guidance for clinical projects, according to the assigned roles and responsibilities. He/she will report to the Head of Clinical Operations US.
Your responsibilities include, but are not limited to:
› Work in conjunction with Medical and/or scientific Expert as applicable, in the creation and seemless execution of deliverables (clinical documents such as plans, protocols, amendments, informed consent forms, study guides, case report forms and any other clinical research related materials)
› To coordinate and manage from a project centric perspective all internal and external project management resources involved in the project
› Provide expertise as required as a contributing author in the preparation, development and review of clinical part of regulatory documents (IMPD, IND, IB, briefing packages…)
› To attend and contribute as required to advisory boards, expert scientific committees
› Ensure projects are carried out according to the protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
› Select and oversee performance of vendors, to ensure compliance with protocol and in accordance with scope of work.
› Participate in the review of clinical study report
› Track and report on progress of project
› Review key study quality metrics (e.g. eligibility, primary endpoint data) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
› Investigate issues, monitor discrepancies, follow-up until resolution
› Assist in identification and selection of investigation sites, and support the sites all along the study in close collaboration with the monitors and the CTMs
› Assist in the follow-up of the budget activities and ensure outsourced activities are completed according to contracted scope of work for assigned clinical trials
› Work with Quality Assurance to identify potential quality issues. Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by CRO
› Assist with inspection readiness activities for assigned clinical trials
› Contribute/participate in development, review and training for SOPs
› BS with a minimum of 8-10 years experience as Clinical Project Manager in a similar therapeutic area
› Ability to coordinate a project in connection with internal and external stakeholders Scientific Knowledge
› Knowledge of “Good Clinical Practice”, applicable ICH in clinical research, and Good Safety Practice.
› Excellent Organizational and communication skills
› English (fluent), and French is a plus
This position is based in our Cambridge office.
If your CV meets our expectations please send your cover letter and CV to Aude Jacheet, at: email@example.com, mentionning the job offer reference.
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +33 (0) 3 2016 4000