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Redwood City, California, United States
Hybrid
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
The Opportunity:
The Senior Clinical Documentation Specialist supports the accuracy, completeness, and timely delivery of relevant documentation supporting clinical trials within CDSAS. This role combines hands-on document coordination and record keeping, helping ensure contracts and study records are complete, traceable, and ready for review, audit, and inspection. The individual independently manages assigned activities and works closely with RevMed Legal and RevMed Finance.
Required Skills, Experience and Education:
BS/BA Degree or other suitable qualification with relevance to the field.
5+ years of experience with electronic trial master file (eTMF) platforms and electronic document management systems, including document metadata, version control, and reporting.
Serve as a point of contact for CDSAS contracts/change orders and purchase order requisitions, which require triaging vendors, RevMed Legal Review, and RevMed Finance.
Manage the CDSAS contracts/change order workflow to ensure timely review, feedback resolution, and signatures.
Prepare, format, quality-check, route, and maintain, for example, supporting CDSAS electronic trial master file documents (eTMF) and contracts.
File assigned records in the eTMF and other designated repositories using established naming, indexing, and filing conventions.
Periodic review of documents inventories for completeness, accuracy, required signatures, dates, and consistency; follow up on missing or deficient records.
Reconcile assigned documentation against study requirements and filing plans; support document transfers, study closeout, retention, and archiving.
Tracking and maintaining 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.
Performing scripted User Acceptance Testing (UAT) and reviewing study-specific UAT records.
Perform assigned activities in accordance with applicable Good Clinical Practice (GCP) and Good Documentation Practice (GDP) requirements, company SOPs, study procedures, and confidentiality expectations.
Preferred Skills:
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, to reconcile document inventories and maintain status trackers.
Familiarity with the TMF Reference Model and 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.
#LI-DN1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
