Note: The job is a remote job and is open to candidates in USA. Advanced 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. 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 Skills • 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 • Experience with Veeva Vault eTMF Benefits • Health coverage • Life insurance • Disability insurance • 401k benefits Company Overview • Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services. It was founded in 1994, and is headquartered in Deerfield, Illinois, USA, with a workforce of 501-1000 employees. Its website is Company H1B Sponsorship • Advanced Clinical has a track record of offering H1B sponsorships, with 8 in 2025, 4 in 2024, 1 in 2023, 3 in 2022, 5 in 2021, 8 in 2020. Please note that this does not guarantee sponsorship for this specific role.