Description
Takeda 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. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S.
Full time. $145,200.00 - $223,200.00 / year.
Apply on-line at and search for Req # R0123794.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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