Job Details:

Job Title: Senior Central Monitor

Duration: 6 Months Contract on w2

Location: San Rafael, CA

Role description:

Support centralized monitoring per the study-specific plan and BioMarin 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 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)

Qualifications:

Bachelors 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.

Preferably, 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.