Position: Senior Central Monitor , Req#: 35590395
Location: San Rafael, CA (100% Onsite)
Duration: 6+ Months Contract
Job Description:
Education and Experience:
- Bachelor's in life science, data science, statistics or mathematics. Preferred master’s degree.
- At least 5+ years of experience in data management or RBQM activities including RACT, KRI, QTLs, etc.
- Preferable, working knowledge of SAS, R, Python, JavaScript, etc.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
- Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously.
- Ability to complete deliverables on time and adjust priorities in a fast-paced environment.
- Ability to work independently as well as collaboratively in a team environment accepting accountability.
- Excellent verbal and written communication skills.
Job Responsibilities:
- Support centralized monitoring per the study-specific plan and the client’s RBM process, through the development and review of study metrics and triggers (in the RBM system) to identify potential critical risks to clinical trial conduct, data quality and patient safety
- Review critical data, processes, and RACT
- Set up/test study data integration with the RBM system to support KRIs, CSM, and QTLs
- Define and implement study key risk indicators (KRIs) in the RBM system by collaborating with cross-functional team members to ensure KRI endpoints and thresholds are fit for the purpose
- Review KRIs and CSM outputs in the RBM system. As needed, review study level operational, patient data, and statistical analyses of accumulating data to support the investigation and root cause analysis of observations
- Track and investigate observations to determine the best mitigation plan and follow-up.
- Communicate centralized monitoring observations to study team/appropriate cross-functional partners and collaborate with Quantitative Science in leading the review discussion regarding the centralized monitoring observations
- Ensure RBM implementation/user access is in sync with DAP (Data Access Plan)