[Remote] Clinical Trial Document Specialist - REMOTE U.S.
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
ā¢ 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
ā¢ Support study setup, including contributing to the development of TMF Plan, TMF Oversight Plan, Expected Documents Lists, and archival/transfer as required
ā¢ Monitor operational metrics to support oversight of the TMF
ā¢ 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
ā¢ Collaborate with the Project Lead to identify TMF risks and ensure compliance with internal and regulatory requirements
ā¢ Oversee the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per standard procedures
ā¢ Maintain and perform oversight reviews (quality checks) of the Trial Master File for all assigned clinical projects
ā¢ Oversee TMF user access management as required
ā¢ Ensure TMF inspection readiness review of TMF is completed and documented
ā¢ Support process improvements as the TMF subject matter expert
ā¢ Attend departmental and trial-specific meetings and discussions, as required
ā¢ Complete other TMF document-related tasks as required
ā¢ Support TMF audits and inspections as required
ā¢ Maintain knowledge of SOPs, DIA reference model, GCP, ICH guidelines, and regulatory standards
Skills
ā¢ 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
ā¢ Excellent written and verbal communication skills
ā¢ Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities
ā¢ Detail-oriented, with strong organizational and time management skills
ā¢ Experience with Veeva Vault eTMF
Benefits
ā¢ Health coverage
ā¢ Life insurance
ā¢ Disability insurance
ā¢ 401k benefits
Company Overview
ā¢ 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 http://advancedclinical.com.
Company H1B Sponsorship
ā¢ 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.
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Responsibilities
ā¢ 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
ā¢ Support study setup, including contributing to the development of TMF Plan, TMF Oversight Plan, Expected Documents Lists, and archival/transfer as required
ā¢ Monitor operational metrics to support oversight of the TMF
ā¢ 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
ā¢ Collaborate with the Project Lead to identify TMF risks and ensure compliance with internal and regulatory requirements
ā¢ Oversee the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per standard procedures
ā¢ Maintain and perform oversight reviews (quality checks) of the Trial Master File for all assigned clinical projects
ā¢ Oversee TMF user access management as required
ā¢ Ensure TMF inspection readiness review of TMF is completed and documented
ā¢ Support process improvements as the TMF subject matter expert
ā¢ Attend departmental and trial-specific meetings and discussions, as required
ā¢ Complete other TMF document-related tasks as required
ā¢ Support TMF audits and inspections as required
ā¢ Maintain knowledge of SOPs, DIA reference model, GCP, ICH guidelines, and regulatory standards
Skills
ā¢ 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
ā¢ Excellent written and verbal communication skills
ā¢ Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities
ā¢ Detail-oriented, with strong organizational and time management skills
ā¢ Experience with Veeva Vault eTMF
Benefits
ā¢ Health coverage
ā¢ Life insurance
ā¢ Disability insurance
ā¢ 401k benefits
Company Overview
ā¢ 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 http://advancedclinical.com.
Company H1B Sponsorship
ā¢ 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.
Apply tot his job
Apply To this Job