Contract to Perm Lead Clinical Data Manager | San Carlos, CA

Job Title: Lead Clinical Data Manager
Location:  San Carlos
Job Category: Clinical Data Management
Travel Required:  25%
Position Type: Contract to Perm

Role and Responsibilities

  • Responsible for all data management tasks from start-up to database close-out.
  • DM lead for internal and external team meetings and communication.
  • Serve as the data management expert for assigned projects.
  • Coordinate the work of both internal and external team members.
  • Anticipate roadblocks and provide practical solutions.
  • Track project progress and issue status report.
  • Oversee initial and post go-live database development
  • Creates and Maintain CDM Documentation:
    • Data Management Plan,
    • CRF Completion guidelines,
    • Edit specifications,
    • Reconciliation guidelines,
    • Data Review Plan,
    • DM listings, and
    • Report specifications.
  • Assist in the creation and documentation of new or revised procedures.

Education Requirements

Bachelor degree in biological science or a related discipline in the science/healthcare field or equivalent education.

Experience

Minimum 8+ years of experience in CDM or Biostatistics in a CRO or pharmaceutical industry, or an equivalent combination of education and experience to successfully perform key responsibilities of the job.

Preferred Skills

  • Thorough knowledge of all technical elements of data management.
  • Understanding of ICH-GCP principles.
  • Thorough understanding of medical terminology and clinical research terminology.
  • Varied therapeutic area experience.
  • Demonstrated ability to provide coaching and training to new hires and less- experienced¬†colleagues.
  • Communicates effectively through both written and verbal methods.
  • Manages time effectively to produce quality deliverables in the expected timeframe.