Specialist, EDC & Clinical Programmer

Specialist, EDC & Clinical Programmer

Ascendis Pharma

Hellerup, Denmark

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.

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.