Sr. TMF Specialist (Contractor)

Senior Clinical Document Specialist

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. This is a 6 month full time contract, remote US.

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

Qualifications

Bachelors or Associates degree and 4+ years of professional clinical trial experience OR a high school diploma and 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

EOE Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets