Clinical Data and Monitoring Lead

Role: Clinical Data and Site Operator

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.

Summary:

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 (ConMeds, 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)