Sr Clinical Trial Manager
- General Studies Mexico City, Mexico Santiago, Chile Panama City, Panama Buenos Aires, Argentina San Jose, Costa Rica São Paulo, Brazil Bogota, Colombia Full time R The Sr Clinical Project Manager provide management of a clinical trial (s) in a global level. Services/deliverables include operational oversight of assigned project(s) 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, Standard Operating Procedures (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 Health care or other scientific discipline Req
- Requires 8 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Minumun 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.
- Nice to have Cell Therapy/Hemayology TA experience.
- Requires good knowledge of project finances.
- Knowledge of clinical trials
- Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.