Description
Are you passionate about Clinical Data? Do you have experience within building eCRFs in the EDC CDMS and clinical programing for complex clinical trials? Are you familiar with clinical data management and programming activities from start-up, conduct to closure of the clinical trial?If so, now is your chance to join Ascendis Pharma as our new
Specialist
, EDC & Clinical Programmer
.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 Specialist, EDC & Clinical Programmer to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in EDC and Clinical Programming activities in clinical data management groups associated with the development, conduct, and management of assigned trials in endocrinology, and future therapeutic areas. 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 Data Management team consisting of 8 colleagues in Denmark 12 in the USA, and report directly to Director of DK Clinical Data Management Operations, who is based in Hellerup office in Copenhagen, Denmark. You will also be based out in the same office.
Your key responsibilities will be:
- Perform the development, configuration, and maintenance of clinical trial databases within the electronic Clinical Data Management System (CDMS) ensuring accuracy, quality, and compliance with clinical trial protocols.
- Serve as a subject matter expert in the review and design of eCRFs in EDC, validation specifications, and database builds, including the programming and testing of edit checks, data reports, data integrations/transfers within the Clinical Data Management System (CDMS).
- Generate and analyze metrics, reports, data listings and visualizations to support clinical data review, and oversight of internal/external data management activities.
- Act as a key player between Data Management, trial teams, and external CROs/vendors to ensure clinical trial requirements are effectively translated into system design and deliverables.
- Ensure strict adherence to clinical database standards, regulatory requirements, SOPs, and internal process guidelines.
- Contribute to continuous improvement initiatives with strategic insights, innovative solutions, and technical expertise to enhance CDM systems, processes, and overall team efficiency.
Qualifications and Skills:
You hold a relevant academic degree – preferably in life sciences (e.g. data science, computer science, pharmacy, biology, statistics) and minimum of 10 years of combined experience within EDC clinical trial databases/EDC development and clinical programming.Furthermore,
you have:
- Demonstrated technical proficiency in Clinical Data Management Systems i.e. Veeva CDMS (preferred), Medidata Rave, Oracle Inform etc. with at least 5 years of database build/development experience.
- At least 5 years of Clinical Programming experience, preferably in SAS or R and SQL.
- Working knowledge of data standards (CDISC CDASH/SDTM) and metadata management.
- Well-versed in the drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning procedures, and 21 CFR Part 11.
- Project management capabilities encompass effective group presentation, leadership, verbal and written communication, interpersonal adeptness, and organizational proficiency.
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 strong team player, proactive in nature and have a can-do attitude. We are looking for someone who possesses an entrepreneurial mindset that can handle ambiguity, analyze, and create clarity.
Travel:
Up to 5 - 15 days per year.
Office:
Denmark, Copenhagen, Tuborg Blvd. 12, 2900 Hellerup
Apply now.
We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time. To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. For more details about the position or the company, please contact hiring manager: Kishan Kumar, Director of DK Clinical Data Management Operations at kku@ascendispharma.com
You can learn more about Ascendis by visiting our website
www.ascendispharma.comApplications must be submitted in English and will be treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.
