Clinical Data Management Specialist
1 month ago
We are seeking a highly skilled Clinical Data Management Specialist to join our team in Copenhagen. As a key member of our Clinical Data Management team, you will be responsible for developing and maintaining clinical databases, ensuring adherence to standards and 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 compliance with regulatory requirements.
- Lead and/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 including evaluation and testing of new systems, help coordinate CDM Systems technical initiatives, and contribute strategies to enhance processes and increase productivity.
To succeed in this role, you will need 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. You must have demonstrated technical proficiency in Clinical Data Management Systems, at least 4 years of EDC database development experience, and at least 2 years of programming experience preferably in SAS and SQL.
You should also possess strong project management capabilities, effective group presentation, leadership, verbal and written communication, interpersonal adeptness, and organizational proficiency. Additionally, you should be proficient in multitasking, independent work, and effective communication. Proficiency in English at a professional level, both written and spoken, is also required.
Salary and BenefitsThe estimated annual salary for this position is approximately €80,000 - €110,000 depending on experience. Benefits include up to 5-15 days of travel per year, a dynamic working environment with short lines of communication and an open and informal atmosphere, and opportunities for growth and development within the company.
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