Director of Trial Master File Operations

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

This position is site based and requires a presence on-site in Bedford, MA three days per week.

Summary of Role

Reporting to the Head of Clinical Operations, the Director of TMF Operations will be responsible for providing strategic planning, oversight, and delivery of the clinical documentation function throughout the lifecycle of Clinical Development programs. This role will work collaboratively and strategically with the Head of Clinical Operations as well as cross-functional teams and external partners to establish standards for TMF-related activities, including: support of a global eTMF system, TMF related SOPs, processes and best practices; development of metrics and tracking of eTMF performance (both internally and externally) to ensure and promote a continuous state of inspection readiness and compliance with regulatory requirements and the principles and standards of GCP, as well as GDPR standards and requirements.

Key Responsibilities

• As Director eTMF, you will act as the TMF Subject Matter Expert for the clinical study team and support cross-functional departments to ensure high-quality documentation.
• Responsible for leading and managing the setup, management, archiving processes, and execution of Veeva, including naming conventions, processes, migrations, etc.
• Ensure the TMF(s) for each project/study are compliant and ready for inspections by auditors and regulatory authorities (TMFs with CRO partners and the internal Veeva Vault system).
• Drive and enforce timelines with a sense of urgency to meet clinical trial deadlines, as well as corporate/department goals and objectives.
• Lead the development/refinement of procedural documents, SOPs, etc., and oversee the creation of individual project TMF management plans and related materials.
• Act as a primary point of contact for project teams for guidance, oversight, metric creation, and review, as well as a key liaison for CROs, auditors, IT, and external parties.
• Review and resolve discrepancies within eTMFs, ensuring timely reporting and internal reviews.
• Participate in clinical operations meetings, audits, and inspection readiness activities, ensuring smooth preparation.
• Identify and implement continuous process improvements in collaboration with key stakeholders.
• Manage budget proposals from third parties related to eTMF activities or systems, ensuring alignment with business needs.
• Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements.
• Guide and provide metrics for CRO and internal TMF systems to reflect TMF status and health accurately.
• Oversee access management and ensure appropriate internal and external access to the eTMF system. Be the system owner and expert for Veeva Vault.
• Ensure compliance with global regulations and guidelines for TMF management, staying current with changes in industry standards.

Job Requirements

• The ideal candidate will have extensive experience with Veeva Quality systems and will be responsible for training and supervising eTMF staff.

• Bachelor's degree or international equivalent in information management, library science, clinical science, or a related field.

• 6+ years of TMF management experience in global clinical trials.

• Experience with computerized clinical trial records management technologies, particularly Veeva systems.

• 4-5 years of management experience, with a proven track record of mentoring and developing teams.

• Strong organizational, writing, and communication skills.

• Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.