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Clinical Trial Manager

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1 Vacancy
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Job Location drjobs

Gentofte Kommune - Denmark

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Description

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 might be a great opportunity for you..

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

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 driving the effective conduct of global clinical trials within our endocrine rare disease programs ensuring timely delivery and high quality to help make a meaningful difference in patients lives. This is an exciting opportunity to work in a fast-paced environment collaborate with cross-functional global teams working together to achieve extraordinary results.

You will be joining the Clinical Operations team consisting of 10 colleagues and report directly to Betina Steenberg Director Clinical Operationswho is based in Hellerup like you will be.

Your key responsibilities will be:

  • Provide operational input to clinical trial protocols and support trial set-up including development of key documents (e.g. consent forms data collection tools management plans).
  • Manage and oversee CROs vendors and clinical trial sites including participation in selection qualification initiation and close-out activities.
  • Monitor trial progress and site performance through metrics recruitment tracking co-monitoring visits and site engagement efforts.
  • Ensure quality and compliance through review of protocol deviations safety data and oversight/QC of the Trial Master File (TMF).
  • Support regulatory and ethics submissions investigator/monitor meetings and contribute to clinical SOPs within the Ascendis Quality Management System.

Qualifications and Skills:

You hold a relevant academic degree a bachelors or masters degree in natural or health science (biology pharmacology pharmaceutical science or equivalent) have minimum five 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:

  • 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.

Key competencies:

You have a strong 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:

  • 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: 5-8 days per year.

Apply now.

Applications will be evaluated when received so please apply as soon as possible.

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

For more details about the position or the company please contact Betina Steenberg Director Clinical Operations on or

You can learn more about Ascendis by visiting our website

Applications submitted via email or other channels will not be reviewed.

Please note: Due to the summer holiday period our response times may be a bit longer than usual. We appreciate your patience and look forward to reviewing your application as soon as possible.


Required Experience:

Manager

Employment Type

Full-Time

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