Senior / Principal Clinical Data Manager

About the Opportunity

We are currently partnered with a full-service pharmaceutical company that’s currently in need of a Sr/Principal Clinical Data Manager. This role is responsible for all data management activities from start-up through closeout of study, and will represent data management in meetings and providing status updates and metrics as needed. This is a fantastic opportunity to advance your career in the field of oncology with a growing organization.

The annual base salary range is $120,000 to $130,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.

 

Job Responsibilities

  • Critically review protocols and provide feedback as it pertains to data collection and data management activities
  • Contribute to the design of study databases, case report forms (CRFs) and edit checks
  • Develop and maintain proper study documentation throughout the lifecycle of a study, to include, but not limited to Data Management Plans, (DMP), eCRF Completion Guidelines, Database Specifications, Edit Check Specifications, and UAT Test Plans
  • Create and validate standard, study specific, and ad hoc study reports
  • Develop training material and provide electronic data capture (EDC) system training for internal users and site personnel
  • Perform serious adverse event (SAE) reconciliation between EDC and safety database
  • Perform coding and review auto-coded terms within EDC using MedDRA and WHODrug dictionaries
  • Ensure that all data management activities leading to database lock are completed; work with the clinical team as needed to ensure timely database lock
  • Perform data transfers from EDC to sponsors
  • Interact with third-party vendors, such as central laboratories, to carry out data management tasks
  • Communicate project statuses and key issues to CPM and study team as needed
  • Participate in cross functional team meetings as requested

 

Job Requirements

  • Bachelor’s Degree in related field
  • Minimum of 5+ years of Biopharmaceutical/CRO experience
  • Knowledge of industry standards, such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines
  • Experience with clinical databases such as Medrio, OpenClinica, Oracle

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