Hiring: Trial Master File Specialist Company: Pharmaron Location: Baltimore, MD Job Posted Time: 2026-09-15 11:46:49 Employment Type: Contract / On-site Target Skills & Keywords : GCP, Microsoft Excel, Microsoft Office, R About the job Experience: •5+ years of TMF, clinical document management, clinical operations, or regulatory experience within a CRO, biotechnology, or pharmaceutical environment, OR Bachelor's degree and 3+ years of TMF or clinical document management experience within a CRO, biotechnology, or pharmaceutical environment. Required Skills: •Play a critical part in ensuring TMFs remain compliant, complete, and inspection-ready while supporting the successful execution of clinical trials. •Develop and maintain TMF Plans and filing strategies. •Serve as the subject matter expert for electronic TMF (eTMF) systems and processes. •Ensure TMFs are maintained in accordance with ICH-GCP, regulatory requirements, and the CDISC TMF Reference Model. •Conduct ongoing TMF quality reviews to ensure document completeness, accuracy, and compliance. •Generate TMF quality metrics and status reports for sponsors and study teams. •Partner with Project Managers and Clinical Research Associates (CRAs) to maintain inspection readiness throughout the study lifecycle. •Support sponsor audits and regulatory inspections, including document retrieval and issue resolution. Qualifications: •Own and manage sponsor Trial Master Files (TMFs) from study start-up through closeout. •Hands-on experience managing electronic Trial Master Files (eTMFs). Compensation: •Competitive benefits and rewards package •Comprehensive Medical, Dental & Vision Insurance with significant employer contributions Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!