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Clinical Trials Project Manager
vor 1 Woche
We are seeking a highly experienced and skilled Global Clinical Trial Leader Early Phase to join our team at Debiopharm. As a key member of our clinical development team, you will be responsible for leading global clinical trials in oncology from initiation to completion.
Your primary focus will be on planning, executing, and managing global clinical trials, ensuring that they are executed flawlessly and meet all quality standards and regulatory requirements.
You will work closely with cross-functional teams, including clinical operations, Clinical Development, regulatory affairs, and data management, to ensure the successful implementation of clinical trial protocols.
In this role, you will have the opportunity to develop and oversee clinical trial budgets, timelines, and resource allocations, ensuring adherence to quality standards and regulatory requirements.
You will also interface with key stakeholders, including CROs, investigators, key opinion leaders, and study sites, fostering strong relationships and effective communication.
Additionally, you will monitor trial progress, identifying and addressing potential issues, and implementing corrective actions as necessary.
This is an excellent opportunity to contribute to the development of clinical development plans and study protocols, ensuring that clinical trials are inspection-ready at all times and Trial Master File (TMF) completion is in place and ongoing QC activities are performed.
- Develop and oversee clinical trial budgets, timelines, and resource allocations.
- Interface with key stakeholders, including CROs, investigators, key opinion leaders, and study sites.
- Monitor trial progress, identifying and addressing potential issues, and implementing corrective actions as necessary.
- Advanced degree in a relevant scientific discipline (MD, PhD, or equivalent).
- Extensive experience in global clinical trial management, including project management, specifically in oncology.
- Proven track record of successfully leading global clinical trials from inception to completion, mainly in Phase I & Phase II.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Experience with health authority inspections (FDA / EMA) and audits preferred.
