EDC/Clinical Programmer

We are seeking a highly skilled EDC/Clinical Programmer to join our team at Ascendis Pharma A/S. As a key member of our Clinical Data Management team, you will be responsible for developing and maintaining clinical databases, ensuring adherence to clinical database standards, and collaborating with internal and external stakeholders to integrate study team requirements into all deliverables.

• Develop and update clinical databases (EDC) to ensure high-quality data management.
• Lead and/or participate in the review of eCRFs and validation checks, database development, and programming of validation checks in Clinical Data Management System (CDMS).
• Interface with members of study teams, including external CROs/vendors, to integrate study team requirements into all deliverables.
• Participate in extra activities, including evaluation and testing of new systems, and help coordinate CDM Systems technical initiatives.
• Contribute to the ongoing development, review, and revisions of Standard Operating Procedures (SOPs), Work Instructions, Training, and standard DM templates.
• Contribute to the development of CDM and EDC standards.
• Generate metric reports and listings to facilitate the management and review of external data, as required.

• A minimum of 6 years of clinical programming and/or EDC database development experience from pharma, biotech, or CRO.
• Relevant academic degree in life sciences (e.g., data science, computer science, pharmacy, biology, statistics).
• Demonstrated technical proficiency in Clinical Data Management Systems (i.e., Veeva CDMS, Medidata Rave, Oracle Inform, etc.).
• At least 4 years of EDC database development experience.
• At least 2 years of programming experience preferably in SAS and SQL.
• Proficiency in cultivating and sustaining positive collaborative relationships across diverse functional areas.
• Keen emphasis on prompt action and prioritizing stakeholder needs.
• Project management capabilities encompassing effective group presentation, leadership, verbal and written communication, interpersonal adeptness, and organizational proficiency.
• Desire to learn new processes and technologies.
• Proficiency in multitasking, independent work, and effective communication.
• Well-versed in the drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning procedures, and 21 CFR Part 11.

As a member of our team, you will have the opportunity to work on exciting projects, collaborate with experienced professionals, and contribute to the development of our Clinical Data Management team. We offer a dynamic and informal working atmosphere, with a focus on innovation and continuous learning.

We are looking for a strong team player with a can-do attitude, who is proactive and has a keen eye for detail. If you are passionate about clinical data management and have a desire to learn and grow, we encourage you to apply for this exciting opportunity.