Senior Clinical Documentation Specialist

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.

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