The Clinical Operations team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I-III studies in oncology, most of them first in class compounds. We are seeking a TMF Administrator and Subject Matter Expert (SME) for our electronic Trial Master File (eTMF) team. This role involves supporting the internal clinical and cross-functional project teams with respect to maintenance, review, metric creation, filing, documentation and organization of the Trial Master File and ensuring it is inspection-ready at all times.

The role

As a TMF Administrator and SME, your main tasks and responsibilities are the following:

Ensure the TMF is compliant and ready for inspections by auditors and regulatory authorities act as an SME, administrator and business owner of the internal eTMF system.
Lead the development of a process for internal upload of documents into the eTMF, the QC, review and oversite processes of the eTMF as well as the creation and necessary editing of procedural documents, Standard Operating Procedures( SOPs), Work Instructions (WIs)TMF management plans and Indices, and all other related materials.
Provide training to all project team members as to the importance of the TMF and a “how to” on the review process of all of the documents within the different TMF sections.
Provide back-up to CTAs and other project team members to support upload to the eTMFs and the review processes as necessary.
Provide review of eTMF metrics and guidance to the project teams in the continuous review of the eTMF (internal & external) and the oversight of the collection of external vendor documents for TMF upload and filing.
Support the cross-functional team in the provision of documents for eTMF upload and the QC of documents in the eTMF according to TMF oversight plan.. Act as an SME on the Veeva quality system for all project teams.
Have participated in TMF migrations and processed all necessary documentation as part of the migration, including the pre and post QC processes.
Be a point of contact for all internal eTMF related questions for cross-functional project teams.
Grant Access for new Users to related Records as CBA and update Merus Veeva eTMF access tracker.

Your Profile

The ideal candidate will have extensive experience with Veeva Quality systems.

Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
Ideally Veeva Quality certified or if not certified, extensive experience in the Veeva quality system
5 years of TMF support experience in global clinical trials.
Experience with computerized clinical trial records management technologies, particularly Veeva systems.
Strong organizational, writing, and communication skills.
Knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.
Demonstrated ability to collaborate effectively across teams and departments.
A strong sense of urgency with the ability to prioritize tasks and meet deadlines.
Proven track record of managing multiple programs simultaneously while maintaining quality and efficiency.

Our offer

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.

Merus N.V. jobs

TMF Administrator and Subject Matter Expert