San Rafael, CA
Senior Central Monitor
Senior Central Monitor
Location: San Rafael, CA( Remote)
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:
- Bachelor's degree in life sciences, data science, statistics, or mathematics required; master's degree preferred.
- Minimum of 5 years in data management or Risk-Based Quality Management (RBQM) activities, including RACT, KRIs, and QTLs.
- Hands-on experience with tools like SAS, R, Python, or JavaScript preferred.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Strong knowledge of clinical research practices, FDA & ICH guidelines, GCP, GCDMP, and related regulatory standards.