Clinical Project Manager (M/F)
September 5, 2023
MedinCell S.A. is a pharmaceutical company that develops innovative long-acting injectable medicines in many therapeutic areas based on our BEPO® technology.
Our mission is to contribute to the improvement and protection of the health of populations across the world. The fair sharing of the value created with all our employees is the foundation of our business model. The sustainability of MedinCell is an essential condition for achieving our objectives.
This triple mission has been at the heart of the company’s DNA since its foundation.
We believe that a strong engagement of all our people is essential for our development. This is why every employee become a shareholder soon after their arrival. Our multicultural and talented People (over 27 nationalities) makes all the difference!
We are looking for a Clinical Project Manager !
Your mission at MedinCell
- Support as appropriate the operational activities for the clinical development unit
- Clinical support to all projects at different stages of development (clinical literature surveys, TTP reviews, project-level risk analyses, briefing books, etc.)
- Ensure the set-up of clinical development plans, in collaboration with the Head of Clinical Development
- Select clinical service providers, evaluate proposal (RFPs, attendance and evaluation of CROs at Bid defense meetings (BDMs), negotiate and make recommendations to the hierarchy
- Ensure qualification of clinical service providers in collaboration with QRC
- Manage budgets & contracts and follow-up in collaboration with project managers
- Oversee subcontracted activities in terms of timelines, quality of deliverables and compliance with good clinical practices ;
- Write/review essential clinical trial documents for regulatory submission (synopsis, protocol, IB, ICF & patient information, (e)CRF, Submission forms, Clinical study report)
- Write/review/approve operational trial documents and plans, including: DMP & DVP, TMF, monitoring plan, data exchange/transfer agreements, statistical analysis plan
- Manage Medincell accounts in regulatory databases (Eudravigilance, EudraCT, Clinicaltrial.gov)
Your profile
Education and background
- 5 years of relevant work experience in project management with knowledge of the clinical development environment
- Ideally Pharm D, Master of Sciences, or a Project Management degree or specialization
- Awareness of full drug development cycle and methodology, as well as regulatory compliance requirements
- Demonstrated project leadership, with experience in end-to-end project conduct and delivery for several clinical projects
- Experience in international and multidisciplinary teams
- Fluency in oral and written English
- Demonstrated ability and conceptual knowledge to produce high quality written documents and presentations, that effectively communicate in a clear, organized and concise manner to clinical and regulatory authorities, senior management and other decision-making bodies.
Skills and requirements
- Effective functioning in a rapidly changing environment and adherence to the values, principles and mission of the company
- Proficiency in self-learning new tools and software
- Consistency, perseverance, listening skills
- Ability to adapt to changing situations
- Strong team spirit and open sharing of clinical information as necessary to all appropriate levels in the company
- Desire to continuously improve and progress
- Strong work ethics
We are always looking for new talented people to join our company, based in Montpellier, and participate in our success.
If this mission sounds appealing to you, we’d love to hear from you!