Trial Start Up Manager
Ascendis Pharma, Denmark

Trial Start Up Manager

Join a fast-growing biotech company in a key project 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 Trial Start Up Manager you will be a key contributor to Ascendis’ most complex and high priority clinical trials by supporting the Lead CTM and trial team during the trial start-up phase. You will do this by leading and tracking time critical activites such as site document collection and tracking, submission to authorities and IRBs and coordination of logistical requirements. You will have frequent communication with site staff, vendors and internal stakeholders. You will report to the Director, Clinical Operations and be part of a truly global clinical organization with locations in US, Germany and Denmark.

Your key responsibilities:

• Plan, drive and coordinate operational aspects of clinical trial start up to ensure fastest possible clinical trial initiation and subsequent enrolment
• Ensure clinical trials are set up according to external regulations and internal procedures
• Liaise with internal and external stakeholders to ensure efficient exchange of knowledge and documents as well as avoidance of responsibility or communication gaps
• Build and maintain a knowledge base of local region/country/site requirements in relation to clinical trial start-up
• Develop and maintain processes and standards to ensure clinical trial start up efficiency
• Clinical Operations’ subject matter expert on the forthcoming EU Clinical Trials Regulation
• Contribute to Ascendis’ clinical Quality Management System

You hold a bachelor’s degree or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) and have minimum eight years of experience

within clinical operations from a CRO or the pharmaceutical industry; including roles related to clinical trial start up.

The successful candidate is structured, organized and a proactive problem-solver, striking the right balance between detail and progress. You are a confident decision maker with strong project management, communication and presentation skills and comfortable working in global/virtual teams across time zones. Ideally you have a very good understanding of adjacent key functions; particularly Regulatory Affairs, Clinical Trial Supply, Logistics, Medical and Compliance.

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: up to three days per month

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 Director, Clinical Operations, Arne Kofoed at + 45 70 22 22 44.

All applications must be submitted in English and are treated confidentially.

Job Rewards and Benefits