Job description
Overview:
Mithra is looking for a Clinical Project Manager to join its Clinical Operations department. Responsibilities:
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium. www.mithra.com
Mithra is looking for a Clinical Project Manager to join its Clinical Operations department.
- Participate to the CRO selection process by reviewing all related documents (i.e. RFP documents …).
- The CPL selects CRO/third parties in collaboration with the CTM/COM.
- Verify that all 3rd party vendors that have been contracted directly by the sponsor have been audited/qualified. Collaborate with the CTM to make sure the partner is qualified by the QA department prior to the study start
- Coordinate the preparation of all study related documents, such as the protocol synopsis, clinical study protocol, ICF, (e)CRF, project plan, insurance, Clinical Study Report … and review the main documents
- Coordinate the development of the safety monitoring plan / safety tables
- Collaborate with the CRO to organize the Investigator/CRA meeting by reviewing presentations or selecting meeting venues
- Check that all activities performed by external partners (CRO, central lab, IWRS provider, …) are performed according to Mithra’s expectations, if delegated to a CSL.
- Closely monitor all work performed by the external partners to ensure the quality of the service with respect to the mutually agreed timelines and budget.
- Ensures Site Initiation Visits and monitoring visit (usually performed by the CRO) are prepared.
- Participate to the site staff training to the use of the investigational product, to the data collection and to the study specific procedures.
- Provide all study related documentation to the CTA in a timely manner to allow the CTA to maintain the Trial Master File throughout the entire study duration and to be ‘inspection ready’.
- Demonstrate leadership and maintain a good relationship with all internal and external partners.
- Participate in all risk management meetings for each study. Ensure Risks are escalated to project and to COM if applicable
- Develop overall budget and timelines at project level in collaboration with COM
- Organize or facilitate the clinical team meeting with the support of the CTA/CSL/CSLa
- Ensure a strategic planning of all clinical studies in accordance with the clinical development plan
- Represent the clinical development in the project team meetings
- Work closely with the COM to put in place preferential partnerships/subcontracting to establish synergies, to improve efficiency and quality for all clinical studies. Make sure the CRO tracker is kept up to date and share the information with the entire team
- Provide support to the development of the Clinical Department by assisting in the review of SOP’s …
- Master in biomedical sciences or other life science degree.
- Minimal 5 years experience in clinical trial related function
- Minimal 2 years experience in CRO/Vendor manager and project management.
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