Job Title

Associate Director, Clinical Data Management (CDM)

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Job Description

Responsible for planning, implementing and managing Clinical Data Management (CDM) activities across ReCor’s global clinical program as well as recognizing and supporting the needs of other functions including Regulatory, Medical & Scientific Affairs.

Responsibilities includes managing a global CDM team, EDC database and technology selections, vendor management, data collection and review, process improvement and ensuring that quality standards are maintained.

Knowledge, Experience, And Skills:

  • Experience working in cross-functional team-oriented environments and capability of working on multiple projects simultaneously
  • Expert level understanding of ISO GCP, GCDMP, 21CFR Part 11 and other global regulatory requirements as they pertain to data management.
  • Working knowledge of data protection requirements including GDPR preferred
  • Working knowledge of EDC systems (e.g. RAVE, Medrio, InForm, etc.)
  • Working knowledge of SDTM/C-DASH
  • Knowledge and experience with MedDRA, WHODrug and other Thesaurus-based classifications
  • Medical Device Industry experience across all stages of global clinical studies
  • Knowledge of CDISC/SDTM.
  • Prefer experience or working knowledge of SAS, R, Python and/or SQL programming
  • Prefer experience or working knowledge of data reporting tools such as Spotfire, JMP Clinical, Tableau

Qualifications:

  • Qualified candidates must have an appropriate BA/BSc degree from an accredited college or university; Higher degree (Masters; PhD) in life sciences, or related field preferred.
  • Minimum of 10 years in CDM experience in relevant Pharma/Medical Device/CRO setting
  • Experience with CDISC therapeutic area standards a plus
  • Proficiency in Microsoft Office tools
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