Contract Senior Clinical Data Manager | San Mateo, CA

Job Title: Senior Clinical Data Manager
Location:  San Mateo
Job Category: Clinical Data Management
Travel Required:  Up to 25%
Position Type: Contract

Role and Responsibilities

  • Work concurrently on multiple data management projects with little to no guidance from Project Data Manager.
  • Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager.
  • Provide input and assistance in the design of Case Report Forms (CRFs).
  • Ability to assist study specific edit check specifications.
  • Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes.
  • Assist with the provision of data management reports in support of project team, Clinical Research Associates (CRAs), investigative sites and sponsor as requested.
  • Describe and demonstrate data review processes to sponsors and auditors when needed.
  • Perform all tasks to relevant SOPs, ICH or other regulatory guidelines in DM.
  • Provide guidance and training to Level 1 and 2 CDM colleagues as well as new hires.
  • Perform other duties as required by the Department.

Education Requirements

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

Experience

Minimum 5+ 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.