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Associate / Director, Clinical Data Management

Cambridge, MA

Posted: 11/15/2019 Employment Type: Direct Hire Job Category: Clinical: Data Management Job Number: 2475

Job Description

Reporting to the Head of Clinical Data Management, the AD/Director, Clinical Data Management will be responsible for leading the data management processes for the Rare Disease therapeutic area at our client.

  • Lead the data management partnership with CROs for studies in the Rare Disease therapeutic area
  • Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
  • Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
  • Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
  • Implement, track and review key performance indicators on data management activity across the Rare Disease program
  • Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
  • Participate in the Data Standards Committee and act as the liaison between the study team members Rare Diseases to standardize data collection and reporting

Requirements / Responsibilities:
  • Master’ s or bachelor’ s degree in computer science or a science-based subject with at least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms (or Doctorate with at least 5 years of experience in industry); or a bachelor’ s degree outside of computer science or a science-based subject with a minimum of 12 years of clinical data management experience in industry, with experience across indications and EDC platforms
  • At least 3 years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
  • Vendor management and oversight experience
  • Strong technical skills across data platforms
  • Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
  • Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
  • Experience in regulatory GCP inspections/audits
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Ability to manage multiple projects in a fast-paced environment
  • Creative, capable problem-solver

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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