Sr Clinical Trial Manager
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The Sr Clinical Project Manager provides management of a clinical trial (s) at the global level. Services/deliverables include operational oversight of assigned projects at the global level for end-to-end project management from start-up through to closeout activities.
Tasks & Responsibilities
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (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.
Essentials Requirements
- Bachelor's Degree in Health care or other scientific discipline.
- Requires 8 years 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.
- Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Specific Cell Therapy TA experience (mandatory).
- Requires good knowledge of project finances.
- Knowledge of clinical trials - skill in applying applicable clinical research regulatory requirements i.e. ICH and GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
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