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Global Clinical Operations Manager

Central London   •  Negotiable  •  Permanent, Full time


Global Clinical Operations Manager

Permanent

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.

Key Responsibilities

- 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.

Key Requirements

- 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 hanna.poole@cpl.com or call 0118 952 2793 for more information.

  • Agency: Cpl Life Sciences
  • Contact: Hanna Poole
  • Reference: JO-2109-476872
  • Updated: 4th October 2021
  • Expires: 1st November 2021

Cpl Life Sciences

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