Description
We are seeking a Senior Clinical Project Manager to provide management of clinical trials at a global level. The successful candidate will be responsible for the operational oversight of assigned projects from start-up to closeout activities.
Responsibilities:
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans)
- Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project's lifecycle
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
Requirements:
- Bachelor's Degree in Healthcare or other scientific discipline
- Requires 8 years of clinical research/monitoring experience or equivalent combination of education, training and experience
- Minimum 3 years of regional/global trial management experience in the pharmaceutical industry or CRO
- In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of project finances and clinical trials
- Cell Therapy/Hematology TA experience is an advantage