Global Clinical Operations Manager
Locations: UK - Remote. Germany - Frankfurt.
Salary: Competitive + benefits.
My client is a global biopharma company who are looking for an individual to join their team as a Global Site Management Lead. You will be responsible for global CSM study-level deliverables at global level and influences, accountable for planning and driving global study-level CSM deliverables against study timelines and serve as a primary functional leader for Study Team and CSM in their assigned studies.
- Develop and drive operational study-level strategy to be executed by CSM Country teams, including risk identification, evaluation, and mitigation to establish alignment with overall study execution.
- Contribute to planning and execution of the clinical programs including content of the protocol and study plans (e.g. IDRP, RAMP, Recruitment Strategy and Plan).
- Provides input into vendor selection and content of site-facing vendor platforms.
- Accountable for CSM study execution and oversight of timeline development and adherence through the study lifecycle.
- Accountable for driving site management activities from study start-up through study closeout ensuring delivery of site selection/activation, subject recruitment, protocol compliance, data quality and adherence to monitoring plan.
- Accountable for site-level risk assessments, risk mitigation execution and remediation of site-level non-compliance.
- Ensuring study and site inspection readiness at all times and assisting with audit responses, as applicable.
- Accountable for the development of the study monitoring plan (SMP) and delivers SMP related training.
- 5 years + of industry clinical research experience including independent monitoring and global project management.
- Previous experience as a CRA
- Full life cycle exposure
- Multiple therapeutic area experience
- Vendor management/engagement
- Global study experience
If this role is of interest, please send your CV to email@example.com or call 0118 952 2793 for more information.
- Agency: Cpl Life Sciences
- Contact: Hanna Poole
- Reference: JO-2109-476872_2
Website: Cpl Life Sciences
- Updated: 4th October 2021
- Expires: 1st November 2021