The Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles.

Responsibilities

More specifically, the Risk Manager must:

• Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs.
• Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
• May have to coordinate with central monitor team and verify work.
• Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
• Guide Project Managers (PMs) in transferring identified risks t...