Trial Master File Specialist
Pharmaron
Summary
In this role, you will play a critical part in ensuring TMFs remain compliant, complete, and inspection-ready while supporting the successful execution of clinical trials.
Job description
Key Responsibilities
- Own and manage sponsor Trial Master Files (TMFs) from study start-up through closeout.
- 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.
- Lead TMF reconciliation activities with study teams and investigator sites.
What We're Looking For
- Associate's degree and 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.
- Proficiency with Microsoft office including outlook, MS-word, excel, etc.
- Hands-on experience managing electronic Trial Master Files (eTMFs).
- Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.
- Familiarity with the CDISC TMF Reference Model.
- Experience performing TMF quality reviews, reconciliation activities, and inspection readiness support.
- Ability to manage multiple studies and competing priorities in a fast-paced environment.
- Excellent organizational, communication, and problem-solving skills.
- Strong attention to detail and commitment to quality.
Requirements
- Associate's degree and 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.
- Proficiency with Microsoft office including outlook, MS-word, excel, etc.
- Hands-on experience managing electronic Trial Master Files (eTMFs).
- Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.
- Familiarity with the CDISC TMF Reference Model.
- Experience performing TMF quality reviews, reconciliation activities, and inspection readiness support.
- Ability to manage multiple studies and competing priorities in a fast-paced environment.
- Excellent organizational, communication, and problem-solving skills.
- Strong attention to detail and commitment to quality.
Benefits
- Medical, Dental & Vision Insurance
- 401(k) Matching
- Paid Time Off
- Paid Sick Leave
- Company Holidays
- Health Savings Account
- Flexible Spending Accounts
- Life Insurance
- Short-term Disability Insurance
- Long-term Disability Insurance
- Employee Assistance Program
- Fertility Support
- Maternity Resources
- Professional Development
Company overview
Pharmaron is a premier global life sciences service provider founded in 2004, offering comprehensive research, development, and manufacturing services throughout the entire drug discovery and development process. As a leading Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO), Pharmaron provides integrated solutions across multiple therapeutic modalities including small molecules, biologics, and cell and gene therapy (CGT) products. The company's extensive service portfolio encompasses synthetic and medicinal chemistry, biology services, DMPK (drug metabolism and pharmacokinetics), pharmacology, toxicology, radiochemistry, CMC (chemistry, manufacturing, and controls), and clinical development services. With over 10,000 employees worldwide and facilities across China, the United States, and Europe, Pharmaron supports pharmaceutical and biotechnology companies in accelerating their R&D programs from early discovery through commercial manufacturing. The company is publicly listed on both the Shenzhen and Hong Kong stock exchanges and maintains a strong commitment to scientific excellence, regulatory compliance, and technological innovation in the life sciences sector.