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Senior Data Manager
2 months ago
We are seeking a highly skilled Senior Data Manager to join our team in Non-Clinical Data Management. As a key player in the drug development process, you will be responsible for ensuring the timely delivery of high-quality project deliverables and coordinating data management processes in designated non-clinical study and submission sections.
Key Responsibilities- Ensure all tasks performed are given priority, conducted, and reported according to customer needs.
- Provide project activity overview to line of business. Prepare and review reports and ensure that validation and study data activities are properly finalized and reported.
- Ensure compliance with current GxP (GLP and GCP) regulations, and the necessary innovative approaches are established for the team, to become a centre of excellence meeting regulatory requirements for handling study data.
- Continuously ensure that processes and programming used in the department always are state-of-the-art and that new approaches are implemented to meet current and future demands.
- Interact with members from external organizations, e.g. CDISC.
- A PhD, MSc or BSc in computer science, information technology or natural sciences.
- A minimum of 3 years of experience as Data Manager.
- Preferably experience in the pharmaceutical industry, including GxP knowledge.
- Experience with SAS and implementation of SEND (Standard for Exchange of Nonclinical Data), SDTM (Study Data Tabulation Model), or with running CDISC clinical studies is considered an advantage.
- Likewise, R and AWS infrastructure experience would be an advantage.
Digital Science & Innovation (DSI) is supporting the digital journey across all our therapy areas in R&ED. In DSI, we work in multidisciplinary teams – in strong collaboration with all areas across R&ED and DD&IT R&ED. We participate in drug development projects across the value chain, from early discovery to pre-clinical development. We engage in external collaborations to ensure access to the latest research and technology enablers, and we automate our labs and processes, and we focus on developing and retaining top talent.
Located in Måløv, Non-clinical Data Management is a part of Research Data Management in R&ED Digital Science & Innovation. Our main task is to handle data management activities in GLP or GCP regulated areas working with standardised data.
The implementation of SEND (Standard for Exchange of Nonclinical Data) requirements is anchored in our department where we have built a simple and effective SAS solution to meet the requirements and support the involved processes. Our department consists of ten data management colleagues and now we are looking forward to welcoming a new and ambitious colleague to our team.
