Senior Clinical Data Management Leader

20+ years clinical trial experience in Phase I – IV clinical studies (from study start-up to database lock activities), represent sponsor at investigator meetings, perform vendors/CROs qualification and audit, vendors/ CROs management, timelines/milestones management, forecast and update study/program budget, clinical site set up/training and monitoring, develop Clinical Data Management Standards.

Relevant Product Types

  • Small Molecule
  • Biologics
  • Monoclonal Antibodies
  • Gene Therapies

Relevant Therapeutic Areas

  • CNS
  • Oncology
  • Dermatology
  • Infectious Diseases

Recent Titles

  • Senior Director of Clinical Data Management
  • Executive Director of Clinical Data Management
  • Senior Data Manager


  • Greater RTP Area
  • Open to remote and travel

Relevant Companies

  • AstraZeneca
  • Small & Medium-Sized Biotechs

Skills & Accomplishments

  • Worked collaboratively with the Clinical team, Biostat, Programming, and Medical Monitor throughout the study cycle.
  • Represented data management in the study Investigator’s Meeting to train clinical site personnel and clinical research associates.
  • Experience with start-up activities including protocol review; CRF design; review database set up and UAT (user acceptance testing); draft, review, and approval of data management documents such as edit checks specifications, data management plan, study timelines, and deliverables, coding guideline, SAE reconciliation guideline, SOW for data transfer, etc.
  • Interpersonal communication (include negotiation skills and conflicts resolution), public speaking, and presentation skills

Tools & Systems

  • Oracle Clinical RDC and InForm
  • Integrated Review
  • DataFax
  • EP90
  • basic SAS programming
  • Access
  • DMS
  • WHODrug
  • MedDRA
  • Microsoft Office (Excel, Word, Project, PowerPoint, Publisher)