Central Risk Manager
Syneos Health
Amsterdam
6 days ago
Central Risk Manager
The Central Risk Manager serves as the subject matter expert for protocol execution risk management, risk-based monitoring strategy, and centralized monitoring within the project team. They are accountable for drafting the initial RBM strategy, working with cross-functional teams to assess risks and adapt the strategy. This remote role is based in Amsterdam and requires expertise in risk assessment and monitoring.
Remote
Full-time
Entry Level
Risk Assessment
Risk-based Monitoring
Salary
Not specified
Core Qualifications
Technical (Must-have)
risk assessmentrisk-based monitoringcentralized monitoringICH/GCPGood Pharmacoepidemiology PracticesRACTdata reviewstatistical monitoring
Soft Skills
coachingmentoringcollaborationproblem solvingcommunication
Key Responsibilities
- Provides advice and subject matter expertise for the development of the monitoring strategy required for the project.
- Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations.
- Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
- Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross-functional review of risks throughout the project.
- Provides advice on the development of functional plans to ensure identified risks are mitigated.
- Assesses tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
- Facilitates review of findings with the internal cross-functional team and sponsor.
- With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
- Provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
- Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
- Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or GPP and country regulations.
- Understands the study scope of work, budget and protocol content for their assigned study.
- Escalates to the PM any risk assessment and centralized monitoring deliverables at risk.
- May participate in business development activities including monitoring strategy and budget input.
Central Risk ManagerRisk ManagementClinical TrialsBiotechnologyFull-timeRemoteAmsterdamSyneos Health