Senior TMF Specialist (Office OR Remote)

Arcus Biosciences•Hayward, CA

5d•$118,000 - $131,000•Remote

About The Position

This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate. The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Arcus SOPs and applicable regulations.

Requirements

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
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

Nice To Haves

Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable

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