DescriptionThis 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
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