Advanced Clinical · 9 hours ago
Clinical Trial Document Specialist - REMOTE U.S.
United States
Contract
Remote
Mid LevelAdvanced Clinical is a global biopharmaceutical company focused on immune-based therapies. The Clinical Trial Document Specialist will support high-quality Trial Master Files (TMFs) for ongoing and completed clinical studies, ensuring compliance with regulatory requirements and ICH-GCP guidelines.
BiotechnologyConsultingHealthcarePharmaceuticalHuman ResourcesInformation TechnologyHealth CareStaffing Agency
Responsibilities
Collaborate with the Project Lead, Clinical Study teams, and CRO to ensure a high level of quality and maintain compliance of TMF through the study life cycle to meet departmental and project goals
Support study setup, including contributing to the development of TMF Plan, TMF Oversight Plan, Expected Documents Lists, and archival/transfer as required
Monitor operational metrics to support oversight of the TMF
Provide Study teams with routine TMF reports and monitor TMFs for completeness and trends, and drive actions with the cross functional teams as applicable when issues or trends are identified
Collaborate with the Project Lead to identify TMF risks and ensure compliance with internal and regulatory requirements
Oversee the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per standard procedures
Maintain and perform oversight reviews (quality checks) of the Trial Master File for all assigned clinical projects
Oversee TMF user access management as required
Ensure TMF inspection readiness review of TMF is completed and documented
Support process improvements as the TMF subject matter expert
Attend departmental and trial-specific meetings and discussions, as required
Complete other TMF document-related tasks as required
Support TMF audits and inspections as required
Maintain knowledge of SOPs, DIA reference model, GCP, ICH guidelines, and regulatory standards
Qualification
Required
Bachelor's degree in biological sciences or related field (or equivalent experience) with related experience in pharmaceutical / biotechnology industry including records management in a GCP-regulated environment
Excellent written and verbal communication skills
Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities
Detail-oriented, with strong organizational and time management skills
Preferred
Experience with Veeva Vault eTMF
Benefits
Health coverage
Life insurance
Disability insurance
401k benefits
Company
Advanced Clinical
Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services.
Founded in 1994
501-1000 employees
H1B Sponsorship
Advanced Clinical 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 (8)
2024 (4)
2023 (1)
2022 (3)
2021 (5)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Julie Ross
President & CEO
Kasey Dudley, SPHR, GPHR, PHR
Manager, People and Culture Business Partner
Recent News
2025-09-24
DelveInsight Business Research LLP
2025-07-01
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