TMF Strategy & Operations Director

Actalent; Bethesda (MD); Hybrid; USD 130,000 - 155,000; Full time

Job summary

Actalent in Bethesda, MD seeks an Associate Director, TMF Clinical Operations to lead TMF strategy and governance across large-scale clinical programs. You will own inspection readiness, ensure data integrity, and drive process improvements while supervising TMF staff and coordinating with sponsors.

The role requires deep TMF expertise, GCP/ICH knowledge, and hands-on eTMF experience, with a hybrid work arrangement in Bethesda, MD. A strong leadership record in pharma/biotech is essential.

Qualifications

• Bachelor’s degree in life science or related field.
• 10+ years in pharma/biotech with progressive leadership.
• Deep TMF strategy, operations, and inspection readiness experience.
• Hands-on experience with electronic TMF systems (eTMF).
• Strong knowledge of GCP/ICH guidelines.

Responsibilities

• Lead TMF strategy, governance, quality, and client oversight.
• Ensure inspection-ready TMF across programs and therapies.
• Oversee TMF governance, processes, and training in line with regulations.
• Provide senior TMF point of contact to leadership and sponsors.
• Manage TMF staff and related operational budgets.

Skills

TMF strategy

Leadership

GCP/ICH knowledge

Stakeholder management

eTMF systems

Regulatory compliance

Education

Bachelor’s degree in life science

Advanced degree (PhD/ PharmD/ MD) a plus

Tools

eTMF tools

Job description

Actalent in Bethesda, MD seeks an Associate Director, TMF Clinical Operations to lead TMF strategy and governance across large-scale clinical programs. You will own inspection readiness, ensure data integrity, and drive process improvements while supervising TMF staff and coordinating with sponsors.

The role requires deep TMF expertise, GCP/ICH knowledge, and hands-on eTMF experience, with a hybrid work arrangement in Bethesda, MD. A strong leadership record in pharma/biotech is essential.