Clinical Risk Manager

Clinical Data Analyst (Pharmaceutical)

Location : San Rafael, CA

7 month Assignment (great potential to extend)

Pay Rate : $40 / hr.

On behalf of our client a leading pharmaceutical client specializing in therapeutics for patients with life threatening rare genetic diseases. The Senior Central Monitor will play a key role in supporting the company’s centralized monitoring efforts for clinical trials, ensuring the highest standards of data quality, patient safety, and regulatory compliance. This role involves collaboration with cross-functional teams to identify and mitigate critical risks, leveraging advanced analytical tools and methodologies.

Key Responsibilities :

• Execute centralized monitoring activities per study-specific plans and RBM processes.
• Develop and review study metrics and triggers within the RBM system to identify critical risks to trial conduct, data quality, and patient safety.
• Conduct thorough reviews of critical data, processes, and Risk Assessment Categorization Tools (RACT).
• Analyze operational, patient, and statistical data to support root cause investigations and mitigate risks.
• Set up and test study data integration with the RBM system to support KRIs, Centralized Statistical Monitoring (CSM), and Quality Tolerance Limits (QTLs).
• Define, implement, and evaluate study Key Risk Indicators (KRIs) in collaboration with cross-functional teams.
• Investigate and track observations, determining optimal mitigation strategies and follow-up actions.
• Communicate centralized monitoring findings to study teams and facilitate review discussions.
• Regulatory Compliance and Access Management :
• Ensure RBM implementation aligns with Data Access Plans (DAP) and regulatory requirements.
• Collaboration :
• Work with Quantitative Science teams to lead centralized monitoring discussions.
• Partner with cross-functional teams to ensure comprehensive risk management practices.

Qualifications and Education :

Salary : $40