Senior Clinical Documentation Specialist

Revolution Medicines • Redwood City, CA

6d • $99,000 - $124,000 • Onsite

About The Position

The Senior Clinical Documentation Specialist supports the accuracy, completeness, and timely delivery of documentation supporting clinical trials within CDSAS. The role combines hands-on document coordination and record keeping to help ensure contracts and study records are complete, traceable, and ready for review, audit, and inspection. The specialist independently manages assigned activities and works closely with RevMed Legal and RevMed Finance.

Requirements

• BS/BA degree or another suitable qualification relevant to the field.
• At least 5 years of experience with electronic trial master file (eTMF) platforms and electronic document management systems, including document metadata, version control, and reporting.

Nice To Haves

• Familiarity with contract lifecycle management, electronic signature, and procurement systems used to track agreements, change orders, and purchase orders.
• Proficiency in Microsoft Excel, including filters, pivot tables, and lookup functions, for reconciling document inventories and maintaining status trackers.
• Familiarity with the TMF Reference Model and the clinical trial document lifecycle, including study startup, conduct, and closeout.
• Prior experience supporting oncology clinical trials or working in a biotechnology or pharmaceutical environment.
• Experience improving document workflows, developing job aids, or helping colleagues adopt consistent filing and tracking practices.

Responsibilities

• Serve as a point of contact for CDSAS contracts, change orders, and purchase order requisitions, triaging vendors and coordinating with RevMed Legal Review and RevMed Finance.
• Manage the CDSAS contracts and change order workflow to ensure timely review, resolution of feedback, and signatures.
• Prepare, format, quality-check, route, and maintain supporting CDSAS eTMF documents and contracts.
• File assigned records in the eTMF and other designated repositories using established naming, indexing, and filing conventions.
• Periodically review document inventories for completeness, accuracy, required signatures, dates, and consistency, and follow up on missing or deficient records.
• Reconcile assigned documentation against study requirements and filing plans; support document transfers, study closeout, retention, and archiving.
• Track and maintain complete records of assigned periodic documentation review activities.
• Support audits and inspections by retrieving requested records, maintaining request trackers, and coordinating responses with document owners.
• Perform scripted User Acceptance Testing (UAT) and review study-specific UAT records.
• Perform assigned activities in accordance with applicable GCP and GDP requirements, company SOPs, study procedures, and confidentiality expectations.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior