Associate Director, Clinical Operations
Are you passionate about clinical trial management and do you want to take part in paving the way in a fast-growing and innovative biopharmaceutical company? Then this is a great opportunity for you…..
As (Senior) Clinical Trial Manager, you will be responsible for the effective conduct of global clinical trials within one of Ascendis’ endocrine rare disease programs. You will be part of the cross-functional trial team driving Ascendis’ clinical trials to completion according to agreed timelines and quality and will therefore contribute to directly to Ascendis’ focus on making a meaningful difference in patients’ lives. You will report to the Director, Clinical Operations and join a team of6 colleagues in a truly global organization with locations in Denmark, US, and Germany.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will be responsible for:
- Leading the trial team with representation from relevant functional areas.
- Responsible for development and authoring of clinical trial protocols in collaborations with the trial team.
- Contributing to the development of patient information/consent forms, data collection forms, eCRF completion guidelines, trial specific manuals etc.
- Participating in selection of relevant CROs and vendors. Management and oversight of contracted CROs and vendors, including establishing vendor management plans.
- Participating in identification, qualification, initiation, and close-out of clinical trial sites
- Developing trial-specific plans, such as Trial Management Plan, Monitoring Plan, Protocol Deviation Plan etc.
- Maintain and report metrics for trial progress and clinical site performance, including start-up activities, and patient recruitment and retention
- Communicating with trial site staff, including investigators, to facilitate relationship and engagement between the Ascendis and trial sites. Participating in co-monitoring visits.
- Reviewing protocol deviations and data listings, and support safety reporting
- Planning and participating in Monitor and Investigator Meetings
- Support IRC/IEC and regulatory submissions, as needed
- Contribute to Ascendis clinical Quality Management System by authoring or contributing to clinical SOPs
Your professional qualifications
You hold a relevant bachelor’s or master’s degree in natural or health science (biology, pharmacology, pharmaceutical science or equivalent) and have minimum five years of experience in managing global clinical trials. You are proficient in English at a professional level, both written and spoken.
Furthermore, you have:
- Project management mindset with a good understanding of the drug development process.
- 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.
As a person, you are:
- Structured, organized and a proactive problem-solver, striking the right balance between detail and progress.
- Team player who understands and appreciates how to build effective relationships with both internal and external stakeholders.
- Flexible and highly committed to delivering outstanding results.
Travel: 10-20 days per year.
Place of work: Ascendis Pharma headquarter resides in a modern and wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
For more details about the position or the company, please contact Vibeke Breinholt, Director Clinical Operations on firstname.lastname@example.org or + 45 61 24 24 84 or visit our website www.ascendispharma.com. All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.