[Remote] Clinical Trial Document Specialist - REMOTE U.S.

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company reputed company on immune-based therapies. The Clinical Trial Document Specialist will support high-reputed company Trial Master Files (TMFs) for ongoing and completed clinical studies, ensuring compliance with regulatory requirements and ICH-GCP guidelines. Responsibilities • Collaborate with the Project reputed company, Clinical Study teams, and CRO to ensure a high level of reputed company 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 reputed company Plan, Expected Documents Lists, and archival/transfer as required • Monitor operational metrics to support reputed company of the TMF • reputed company Study teams with routine TMF reports and monitor TMFs for completeness and trends, and drive actions with the cross functional teams as applicable reputed company issues or trends are identified • Collaborate with the Project reputed company to identify TMF risks and ensure compliance with internal and regulatory requirements • reputed company the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per reputed company procedures • Maintain and reputed company reputed company reviews (reputed company checks) of the Trial Master File for reputed company assigned clinical reputed company • reputed company TMF user reputed company 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-reputed company 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 reputed company field (or equivalent experience) with reputed company experience in pharmaceutical / biotechnology industry including records management in a GCP-regulated environment • Excellent written and verbal communication skills • Proficiency in reputed company, reputed company, and Project, with strong analytical and problem-solving abilities • Detail-oriented, with strong organizational and time management skills • Experience with reputed company Vault eTMF Benefits • Health coverage • Life insurance • Disability insurance • 401k benefits reputed company • reputed company is a pharmaceuticals company offering CRO, FSP, reputed company, 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 http://advancedclinical.com. Company H1B Sponsorship • reputed company has a reputed company 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. Apply tot his job Apply To this Job