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Company Contact Info
- Cambridge, MA
- Gregg Kelley
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Sr. Clinical Data Manager
EPM Scientific • Cambridge, MA
Posted 1 month ago
Seeking a Senior Clinical Data Management Consultant to lead the Data Management activities for both Oncology and Rare Disease programs. This position will initiate best practices and lead clinical data management initiatives across the ventures as well as support the oversight of data management vendors and data handling. This role will report to the Head of Clinical Data Management
Requirements (at least relevant or close)
Bachelor's Degree in a science-based subject expertise.
At least 8 years of clinical data management experience in industry, with experience with Medidata Rave® and experience with JReview® reporting software
Early and late development experience; experience with oncology indications is a must
Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.
Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Creative, capable problem-solver