Clinical Data Manager Mid-Level (Remote) Job at Penfield Search Partners, Fairfield, OH

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  • Penfield Search Partners
  • Fairfield, OH

Job Description

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

We are partnering with a growing biotech organization seeking a Clinical Data Manager to support ongoing and upcoming clinical programs across multiple Programs

This role will sit within a cross-functional clinical development team and support end-to-end data management activities with a strong focus on execution quality and collaboration. The ideal candidate brings solid hands-on data management experience with exposure to Phase II & III trials in a fast-paced biotech environment.

Key Responsibilities

  • Support clinical data management activities across studies from start-up through database lock
  • Partner with CROs and vendors to ensure high-quality timely data delivery
  • Collaborate cross-functionally with Clinical Biostatistics Programming and Medical teams on data collection and review strategies
  • Contribute to development and review of key deliverables including:
  • Data Management Plans (DMPs)
  • eCRF design and completion guidelines
  • Edit checks and query logic
  • User Acceptance Testing (UAT)
  • Data review and cleaning processes
  • Perform ongoing data review and support query management to ensure data quality and consistency
  • Support implementation of data standards and process improvements
  • Assist with inspection readiness and ensure compliance with regulatory requirements and industry standards

Qualifications

  • BS in a scientific or clinical discipline
  • 58 years of clinical data management experience within biotech pharma or CRO environments
  • Hands-on experience with EDC systems (e.g. Medidata Rave Oracle Veeva)
  • Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
  • Experience supporting Phase II or III clinical trials; CNS experience is a plus
  • Exposure to CRO/vendor oversight
  • Understanding of data structures and dictionaries (e.g. MedDRA WHODrug)
  • Strong collaboration skills and ability to work cross-functionally
  • Detail-oriented proactive and comfortable in a dynamic environment

Required Experience:

Manager

Job Tags

Contract work, Remote work

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