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Senior Manager, Clinical Data Management
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- Job DescriptionTakeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
- Prior experience must include: Develop and maintain study-specific data management documentation such as CRF Specifications, Edit check specifications, Data Management Plan, and Data Cleaning Plan documentation, etc.
- design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions).
- Up to 20% travel required.
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