Arcus Biosciences · 2 days ago
Sr. TMF Specialist (Contractor) (Office OR Remote)
United States
Contract
Remote
Mid, Senior Level
4+ years expArcus Biosciences is a company focused on clinical research, and they are seeking a Senior TMF Specialist to manage and maintain essential regulatory documents for the Trial Master File. This role involves working closely with study management teams to ensure compliance with Good Clinical Practice and regulatory guidelines, while also providing support to TMF content owners and participating in audit and inspection readiness activities.
BiopharmaBiotechnologyClinical TrialsHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
Review and classify documents collected from internal and external sources
Reconcile essential documents to avoid duplication
Support study teams with the TMF quality review process
Perform QC and maintenance of eTMF for assigned studies
Perform data entry and reconciliation in various clinical systems and tracking tools
Provide input on revision of TMF related Work Instructions and SOPs
Support the management and oversight of the CRO study-specific trial master files
Support the coordination of the transfer of study-specific trial master files from the CRO
Follow up on quality findings
Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing
Participation in audit, inspection readiness preparation and inspection activities as needed
Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF
May provide training and mentoring activities for new and current staff
Develop metrics, reports, and TMF tools/trainings
Act as stand-in leading team meetings, managing team tasks as needed
Position may require occasional travel
Qualification
Required
Bachelors or Associates degree and a minimum of 4 - 6 years of professional clinical trial experience OR a high school diploma and a minimum of 6 years of clinical support experience with essential regulatory documents
Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
Experience with Veeva Vault electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents
Working knowledge of DIA reference model
Works under general supervision and guidance. Works with manager to establish priorities and timelines
Strong computer skills (MS Office) including exposure to data/document management systems
Must be able to work quickly, prioritize effectively, and show attention to detail
Good communication and interpersonal skills
Good time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment
Team oriented and flexible; maintaining integrity and high ethical standards
Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor
Preferred
Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
Company
Arcus Biosciences
Arcus Biosciences is a biopharmaceutical company that discovers, develops, and commercializes novel therapies for the treatment of cancer.
501-1000 employees
H1B Sponsorship
Arcus Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (15)
2023 (18)
2022 (20)
2021 (15)
2020 (10)
Funding
Current Stage
Public CompanyTotal Funding
$1.52BKey Investors
Hercules CapitalGilead SciencesGoogle Ventures
2025-10-30Post Ipo Equity· $250M
2025-02-18Post Ipo Equity· $150M
2024-08-27Post Ipo Debt· $150M
Leadership Team
Terry Rosen
CEO
Juan Jaen
President, Co-Founder, Board of Directors
Recent News
2025-12-18
2025-12-16
Company data provided by crunchbase