Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
- Acts as a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.
- Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.
- Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met.
- Performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives; responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools; manages projects resourced externally via contract research organizations or corporate partners.
- Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite).
- Clinical data management system experience (EDC Medidata Rave preferred).
- Ability to apply advanced principles, theories and concepts for CDM as a whole.
- Understanding of the conceptual basis for data management conventions, standards and processes. Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
- Ability to develop solutions to complex problems.
- Ability to multi-task and effectively set own priorities.
- Strong organizational skills. Strong communication and interpersonal skills.
- A./B.S. or equivalent with a minimum of 5 years’ experience in Clinical Data Management.