Trial Master File Specialist

Pharmaron Beijing Co. Ltd.; Baltimore (MD); Vor Ort; USD 65.000 - 80.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

401(k) Retirement Plan

Paid Time Off

Zusammenfassung

Pharmaron is seeking a Trial Master File Specialist to ensure TMFs are compliant, complete, and inspection-ready for clinical trials in Baltimore, MD on-site. You will own sponsor TMFs from study start-up through closeout, develop TMF plans, and act as the SME for eTMF systems, ensuring adherence to ICH-GCP and CDISC TMF standards.

The role requires strong attention to detail, excellent organizational and communication skills, and the ability to manage multiple studies in a fast-paced

Qualifikationen

• 5+ years TMF, clinical document management, or regulatory experience in CRO/biotech/pharma.
• Associate's degree with 5+ years TMF experience.
• Bachelor's degree with 3+ years TMF experience.
• Proficiency with Microsoft Office including Outlook, Word, Excel.

Aufgaben

• Own and manage sponsor 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.
• Ensure TMFs are maintained in accordance with ICH-GCP guidelines and regulatory requirements.
• Conduct ongoing TMF quality reviews to ensure completeness, accuracy, and compliance.
• Generate TMF quality metrics and status reports for sponsors and study teams.
• Partner with Project Managers and 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.

Kenntnisse

TMF management

Clinical docs

ICH-GCP

eTMF

Regulatory knowledge

Ausbildung

Associate degree

Bachelor's degree

Tools

MS Office

Outlook

MS Word

Jobbeschreibung

Position: Trial Master File Specialist

Hourly Range: $65,000 – $80,000

Location: Baltimore, MD (On-site)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

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.

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.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture:

You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits:

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

As an Equal Employment Opportunity and ...