Trial Master File Lead

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Are you a seasoned TMF expert ready to make a real impact

Were seeking an experienced Trial Master File (TMF) Lead to join our dynamic clinical research team and drive excellence in Trial Master File management across the entire clinical trial lifecycle.

In this pivotal role youll be the guardian of TMF quality and compliance ensuring every study meets the highest standards of inspection readiness. Youll lead from day onefrom strategic TMF planning through to successful study close-outwhile mentoring the next generation of TMF professionals and partnering with Sponsors and internal teams to deliver exceptional results.

Key Responsibilities:

• Lead TMF Strategy & Planning: Develop comprehensive TMF plans align stakeholders on study requirements and establish robust oversight processes that set studies up for success
• Ensure Quality & Compliance: Oversee TMF completeness and quality proactively identify and mitigate risks and maintain inspection readiness at all times
• Drive Continuous Improvement: Monitor TMF health using established metrics resolve issues and champion best practices across the organization
• Be the Inspection Expert: Represent TMF during audits and inspections with confidence prepare documentation and contribute to successful regulatory outcomes
• Mentor & Develop Talent: Share your expertise through training guidance and mentorship building a culture of TMF excellence within your team
• Enable Study Success: Collaborate across functions to support study close-out and ensure seamless TMF archival

Key Requirements:

• 5 years as a TMF Lead in clinical research or CRO environments
• Deep expertise in TMF management inspection readiness and clinical trial regulations (ICH-GCP FDA EMA standards)
• eTMF system proficiency you know the platforms inside and out
• Strategic thinker who can juggle multiple priorities assess complex risks and drive solutions in fast-paced settings
• Exceptional communicator with proven stakeholder management skills and the ability to build strong relationships with internal and external partners
• Bachelors degree in Life Sciences or related field (or equivalent relevant experience)
• Passion for quality and a commitment to regulatory excellence

Why Join Us

• Work with a leading clinical research organization committed to innovation and compliance
• Lead meaningful projects that directly impact patient safety and regulatory success
• Develop your career with opportunities to mentor influence strategy and grow as a TMF expert
• Collaborate with talented dedicated professionals who share your commitment to excellence
• Competitive compensation and comprehensive benefits package

If youre an experienced TMF professional looking for a role where your expertise is valued and your impact is visible wed love to hear from you. Apply now to become a key driver of TMF excellence in our organization.

Employment Type : Full-Time
Experience: years
Vacancy: 1