Work as part of Clinical Development Operations group. Responsible for the data management aspects of clinical trials and works closely with Data Management (DM) CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Drug Safety, and Data Visualization/Data Repositories. Activities include all data management aspects of collaborating with vendors in setting up, managing and completing trial database systems within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data. Specific responsibilities include the following: (1) Serve as Lead Data Manager for assigned projects, including overseeing vendor performance and deliverables; managing assigned DM timelines and ensure deliverables/timelines are met; working with the cross-functional representatives for each study to ensure that the database captures all critical data; and coordinating, gathering and providing necessary clinical data/reports for internal DMC meetings. (2) Provide data management support (directly and/or through vendor management) for ongoing trials, including understanding/following and creating Data Management Plans (DMP), validation specifications, etc.; participating in UAT for each database build/work with vendor to understand the impact of any mid-study updates to the EDC database; reviewing electronic case report forms (eCRFs) for completeness, content and database considerations; performing data review for quality issues and general data trends; overseeing reconciliation activities using data from external vendors; managing and creating reports and/or metrics to track and report data/query status; assisting in the development of data management standard working practices; and assisting in creating data visualizations, as required, for presentations. (3) Participate in data management activities in support of new clinical trials, including serving as DM representative at study team meetings; providing input into study protocols from a data management perspective; participating in eCRF and database design; generating Data Management deliverables including Data Validation Specifications and CRF Completion Guidelines; and working on process improvement initiatives.
Must have BS in Biotechnology, Clinical Data Management, or closely related field, and 2 years of clinical data management experience in the pharmaceutical/biotechnology industry. Must have some experience with analyzing clinical data, specifically oncology or hematology; completing and updating Case Report Forms and resolving issues with study data; working with EDC platforms and processes; developing Data Management Plans for clinical trials; reviewing study Protocols, Case Report Form (CRF) and Reports; and developing and implementing database clinical trial specifications, using SAS, listing review, query logic and data validation.