Roles and Responsibilities: Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc. Contribute to the design of protocols. Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing. Develop protocol specific edit check specifications, participate in user acceptance testing. Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents.
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