Clinical Trial Manager

Clinical Trial Manager

Ascendis Pharma

Hellerup, Denmark

We are seeking a passionate Clinical Trial Manager to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the effective conduct of our global clinical trials within one of Ascendis’ endocrine rare disease programs. You will be part of the trial team driving Ascendis’ clinical trials to completion according to agreed timelines and quality and will therefore contribute directly to Ascendis’ focus on making a meaningful difference in patients’ lives.

Your key responsibilities will be:

• Operational set-up of the trials, including selection and management of vendors, contribution to operational management plans, such as Trial Management Plan, Monitoring Plan, Protocol Deviation Plan etc.
• Contributing to the development of patient information/consent forms, data collection forms, eCRF completion guidelines, trial specific manuals etc.
• Participating in identification, qualification, initiation, and close-out of clinical trial sites.
• Communicating with trial site staff, including investigators, to facilitate relationship and engagement between the Ascendis and trial sites. Participating in co-monitoring visits.
• Oversight and QC of the TMF.

Qualifications and Skills:

You hold a relevant academic degree – preferably a bachelor’s or master’s degree in natural or health science (biology, pharmacology, pharmaceutical science or equivalent) and have at least two years of experience in managing clinical trials. You have experience with day-to-day operational management and oversight of clinical trials. You are proficient in English at a professional level, both written and spoken.

Furthermore, you have:

• Experience with all aspects of clinical trial conduct from planning and start-up, through maintenance and to closure.
• Thorough understanding of GCP and relevant regulatory guidelines and know how to apply it to your work.

Key competencies:

• You are a strong team player, analytical, and have a can-do attitude.
• You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
• To succeed in this role, we also expect you to be a structured, organized and proactive problem-solver, with the ability to strike the right balance between detail and progress.