For one of our clients we are urgently looking for an experienced Clinical Project Manager.
- Do you have several years of experience as Clinical Project Manager?
- Can you take the lead in global programs with regional PM's?
- Are you available soon?
Then you might be the perfect match! We can also collaborate with freelance PM's.
The Project Manager provides leadership to a cross-functional study team in the execution of the clinical research projects. He/ she contributes in the initial study planning, setup and conduct of the project until final reporting phase. This in accordance with the agreed budgets, timelines and company procedures and standards.
You are responsible for:
- Planning of budget, resources and timelines for allocated studies
- Initiation and participation in Process Improvement initiatives
- Project accountability from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (comply with company processes, ICH-GCP and applicable regulations and guidelines)
- Vendor management: from initiation and coordination of the vendor selection process to being the contact person for vendors and making sure the study plans, timelines and budget are respected
- Coordination of study document creation (Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report,…)
- Review and/or approval of study documents (Monitoring Plan, TMF plan, Safety Plan, eCRF, a.o.)
- Manage the appropriate filing and archiving of TMF - Internal single point of contact for assigned clinical studies, close interaction with functional experts involved in the clinical study (Medical Monitor, ClinPharm/PD lead, DM, Stat, CMC,…)
- Organisation of cross-functional Internal Clinical Study Meetings as well as vendor meetings on a regular basis.
- Follow-up with the Quality Monitor and follow-up on audit reports & CAPA set-up and resolution
- Demonstrated capability and experience as Clinical Project Manager in a pharmaceutical or biotech company
- Master's degree or PhD in life sciences, equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
- Fluent in English (written and spoken). Any other language is an asset.
- Good knowledge of ICH/GCP
- Experience with vendor management / CRO oversight is an asset
- Strong problem-solving and leadership skills.
- Ability to prioritize and delegate.
- Stress resistant and a strong team player with the ability to work independently without supervision.
- Willing to travel (domestic and international) as needed.
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