Clinical Programmer with Data Expertise
3 weeks ago
About the Role
">We are seeking a highly skilled 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 regulatory guidelines, and collaborating with cross-functional teams to deliver high-quality study data.
Main Responsibilities:
">- ">
- Develop and update clinical databases (EDC) to ensure accuracy and reliability of study data;">
- Ensure adherence to clinical database standards, SOPs, and process guidelines to maintain compliance;">
- Lead or participate in the review of eCRFs and validation checks, database development, programming of validation checks in Clinical Data Management System (CDMS);">
- Interface with members of study teams, including external CROs/vendors where applicable, to integrate study team requirements into all deliverables;">
- Participate in extra activities, such as 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;">
Your Profile:
">We are looking for a candidate with a minimum of 6 years of clinical programming and/or EDC database development experience from pharma, biotech or CRO and a relevant academic degree in life sciences (e.g., data science, computer science, pharmacy, biology, statistics).
">In addition, you should have:
">- ">
- 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;">
You are proficient in English at a professional level, both written and spoken.
">About the Company:
">Ascendis Pharma A/S is a fast-growing biopharmaceutical company applying its TransCon technology to build a leading, fully integrated biopharmaceutical company with an independent pipeline of long-acting prodrug therapies that address unmet patient needs.
">Location and Travel:
">The position is based in our office in Hellerup, Denmark, with occasional travel up to 5-15 days per year.
">Salary:
">The estimated salary for this position is approximately DKK 850,000 - DKK 1,100,000 per annum, depending on qualifications and experience.
">How to Apply:
">Please submit your application in English as soon as possible.
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