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 http://advancedclinical.com.
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.