Associate Director – Director, eTMF

Title: Associate Director – Director eTMF

Location: Cambridge, MA or Utrecht, NL

Company Overview

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients’ lives. We have bold aspirations, because the need is great and the patients are waiting. Join us and make an impact.

Your role

We are seeking an Associate Director for our electronic Trial Master File (eTMF) team. This role involves leading the eTMF team and overseeing the management of all eTMF activities, ensuring that the Trial Master File is inspection-ready at all times.

In This Role You Will

• 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.
• Lead and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert.
• Be responsible for the setup, management, archiving processes, and execution of Vault, including naming conventions, processes, migrations, etc.
• Ensure the TMF(s) for each program 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 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 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 at Merus.
• Ensure compliance with global regulations and guidelines for TMF management, staying current with changes in industry standards.
  
  

Your Profile

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.
• 8-10 years of TMF management experience in global clinical trials.
• Experience with computerized clinical trial records management technologies, particularly Veeva systems.
• 4-5 years of personnel 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 regulatory requirements.
  
  

Our offer

We offer a competitive salary and flexible working hours. Our talented international team works in Cambridge, MA, USA and in an inspiring area of Utrecht (Utrecht Science Park) in a brand new state-of-the-art facility. We also offer an excellent pension scheme, company bonus on a full-time position. We care about team spirit and organize several company events each year.