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Senior Manager, Clinical Data Management

Summary The Senior Clinical Data Manager (Sr. CDM) will be primarily responsible for quality review and data cleaning of clinical trials. Specific Responsibilities: Conducting and supporting data reviews Submitting queries to vendors Follow up on query resolution Development of data validation specifications and collaboration with clinical programmers to program specifications Assist in review and approval of vendor data management documentation, such as CCGs, Data Management Plans, and Data Validation Plans Qualifications / Requirements: Bachelor's degree in a related scientific field and at least 10 years' data management experience Demonstrated ability and experience overseeing external vendors Preferred Experience, Special Skills, Knowledge: Knowledge and experience with various clinical databases and key technologies (e.g., EDC, CTMS, IVRS/IWRS, CDISC) Working knowledge of GCP, ICH, FDA, and regulatory guidelines Excellent verbal communication, writing and interpersonal skills Self-sufficient and able to work with minimal oversight
Salary Range: NA
Minimum Qualification
11 - 15 years

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