Clinical Data Manager will provide technical and day-to-day application support for the Clinical Affair Organization. He/she will design, program, manage and document database projects and ensure process improvement and the promotion of new tools and techniques. This position is responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials.
Duties & Responsibilities:
Develop the data management plan for clinical studies.
Execute the data management plan throughout lifecycle of the study.
Participate in developing the case report form (CRF).
Develop database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Develop data transfer agreement(s) between external data sources and/or labs.
Assist in database upgrades/migrations including performing user acceptance testing
Maintain/track of EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts.
Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Perform database lock and freeze activities.
Coordinate the archiving of study databases and related documents.
Perform close-out audits
Ensures data system compliance by following the established guidelines of regulatory authorities.
Bachelor’s degree in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related fields and 3+ years’ experience.
Must have knowledge and experience with Medidata.
Capability of Medidata study building.
Project management and delegation skills.
Strong communication skills.
Knowledge and experience in developing study dataset specifications.
Previous work experience in a diagnostic, medical device or pharmaceutical.
Understanding of validation requirements for software tools in a plus.
Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.