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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

Job Snapshot

Degree - 2 Year Degree

Job Description

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

Job ID: 299921/001
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