RIF. 3074: CLINICAL DATA MANAGER
Our Client: a leading international pharmaceutical company
Provision of adequate sponsor oversight to data management processes performed by CRO’s and/or external data providers (e.g. for ePRO data, laboratory data).
Implementation and supervision of data management start-up, maintenance and completion activities and relevant documentation (data management plans, data validation plans and other study specific procedures) within assigned clinical trials.
Monitoring and supervision of the set-up, validation and maintenance of CDMS systems (eTools like EDC, IRT) including Sponsor testing activities and archiving of relevant trial documentation.
Develop and maintain Clinical Database Build specifications (CDISC based).
Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
Attending internal/CRO meetings as required, interacting and collaborating directly with the assigned project manager and other specialty team members (clinical, programming, statistics, drug safety, drug supply etc.) to provide data management support to ensure consistent data handling and quality.
Master’s Degree in Scientific Subjects, Mathematics, Statistics
Fluency both in oral and written English
OFFICE SAS (Opt)
Place of work: Milan