Clinical Data and Monitoring Lead

Clinical Data and Monitoring Lead

South San Francisco, California, United States

This role owns the operational execution and data integrity of the NEW study. Crucially, this is an execution and triage role, not a final Medical Monitor role. The clinical safety and eligibility decisions reside with the company's internal MDs. This position ensures the data reaching the MDs is clean, timely, and actionable.

Remote & Onsite Data Verification (Replacing RMV & IMV)

• Clean, fully verified EDC data ready for sponsor review, delivered via tech-enabled efficiency rather than brute-force hourly logging.
• Execute 100% Source Data Verification (SDV) directly across EMRs (Epic/Cerner) and Medidata Rave.
• Efficiently process high-volume log lines (Con Meds, AEs, Transfusions) specific to Sickle Cell and Cell Therapy.

Clinical Triage & Signal Detection

• Synthesized safety summaries and flagged clinical events requiring MD attention.
• Act as the first line of clinical review. You are not making the final medical call; you are separating the "noise" (routine lab variances) from the "signals" (Grade 3+ AEs, VOCs, DLTs) so the internal Medical Monitor (CEO/MD) can make rapid, informed decisions.

Site Activation & Expansion (Replacing SIV & PSSV)

• "Ready-to-Enroll" clinical sites fully trained on Kamaus complex cell therapy logistics.
• Conduct targeted Pre-Study (PSSV) and Site Initiation (SIV) visits. Focus heavily on the operational logistics unique to our trial: apheresis scheduling, collection cycles, conditioning, and infusion coordination.

Systems & CRO Oversight (Replacing "Admin Retainer")

• A frictionless EDC architecture and held-to-account CRO vendors.
• Proactively identify logic errors or missing fields in the Medidata build (e.g., forms failing to auto-populate) and force the CRO/Data Management to execute formal migrations/fixes.
• Administrative overhead is not a billable existence; it is the proactive management of systems to reduce friction for the sites and the sponsor.

Visit Lifecycle Management

• Predictable, unit-complete monitoring cycles.
• Own the end-to-end "Visit Unit - from pre-visit preparation and system checks, to execution, query generation, and final trip report delivery-without requiring separate administrative bloat.

Key areas of activity:

• Onsite Monitoring Visit (IMV)
• Remote Monitoring Visit (RMV) - Data Review, Query Generation, and Reporting
• Site Initiation Visit (SIV) - prep/training
• Pre-Study Visit (PSSV)