eTMF Manager
Join a fast-growing biotech company in a key process support role
Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become involved in the development of ground-breaking therapies in the clinical setting.
As eTMF Manager you will be responsible to support several trials across our development projects. We have recently implemented an in-house eTMF solution and you will have the opportunity to further develop this process in collaboration with other process specific roles as well as end users of the system. You will ensure proper setup and maintenance of our trial eTMFs in collaboration with our trial teams and a group of student assistants dedicated to document upload and QC.
You will assume a key role in both the setup of new eTMFs in our in-house system as well as ensuring migration of eTMFs from several CRO systems to our in-house system.
You will report to the Associate Director, Clinical Trial Support and be part of a truly global development organization with locations in US, Germany and Denmark.
Your key responsibilities:
You hold a bachelor’ or master’s degree in information sciences or natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) or have another relevant background and experience. You have a minimum of 5 years of relevant experience, preferably in a global role. You have hands-on experience with maintenance of an eTMF in Veeva Clinical Vault.
The successful candidate has a pragmatic and end to end mindset with good understanding of clinical trials. You have a proven track record of shaping and maturing processes and thrive in an environment with competing priorities. You know GCP and regulatory guidelines and know how to apply them to your work.
You are structured, organized and a proactive problem-solver, striking the right balance between detail and progress. You are a team player who understands and appreciates how individuals are different to build effective relationships with both internal and external stakeholders in global teams, both virtually and face to face. You have high proficiency in English with strong communication skills.
At Ascendis Pharma, you will be part of a stimulating, informal and innovative working environment, where you will interact with both colleagues and partners to deliver on Ascendis’ ambitious corporate goals.
Travelling: 10 - 15 days
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
For more details about the job or the company, please contact Associate Director, Clinical Trial Support, Morten Throup Pedersen at +45 30 80 58 40.
We will be conducting interviews on an ongoing basis, so please don’t hesitate to apply if you are interested and qualified.