Senior Tmf Specialist (Office Or Remote)

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. The core duties and responsibilities of the Senior Clinical Document Specialist include, but are not limited to:

Responsibilities

• Support the coordination of the transfer of study-specific trial master files from the CRO
• Provide input on revision of TMF related Work Instructions and SOPs
• Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
• Support study teams with the TMF quality review process
• Follow up on quality findings
• Act as stand-in leading team meetings, managing team tasks as needed
• Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
• Reconcile essential documents to avoid duplication
• Perform QC and maintenance of eTMF for assigned studies
• Participation in audit, inspection readiness preparation and inspection activities as needed
• May provide training and mentoring activities for new and current staff
• Develop metrics, reports, and TMF tools/trainings
• Support the management and oversight of the CRO study-specific trial master files
• Review and classify documents collected from internal and external sources
• Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF
• Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing.
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Position may require occasional travel

Qualifications

• 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
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Experience with electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents.
• Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
• Works under general supervision and guidance. Works with manager to establish priorities and timelines
• Good communication and interpersonal skills
• 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
• Good time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment
• Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor
• Working knowledge of DIA reference model
• 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
• Team oriented and flexible; maintaining integrity and high ethical standards

This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $95,000 - $110,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

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