Clinical Data Management III

Department/Group: Biometrics
Location: Burlingame, CA
Position Type: Full time

Job Description

Role and Responsibilities

  • Review clinical study protocol development.
  • Collaborates and coordinates with cross-function members to design, test and implement data collection systems, such as case report forms (CRF), interactive web response systems (IWRS), and electronic data capture systems (EDC).
  • Develops data quality plans and metrics
  • Manage vendors and contract research organizations (CRO) including generating timelines
  • Proactively and effectively oversees data management activities, identify and resolve issues when arise with internal and external relevant parties.
  • Demonstrate knowledge of hands-on effort
  • Ensures projects are conducted in compliance with operating procedures and good clinical practices
  • Ensures CDM project documentation is in an audit-ready state
  • Author and review CDM operational documents such as SOPs, Work Processes, and associated documents affecting CDM
  • Represent data management on project teams, promote and maintain positive, productive, and collaborative working relationship with internal customers and external vendors
  • Recommend alternative work processes to improve on CDM process, timeliness and data quality and integrity
  • Support regulatory submission activities for assigned projects
  • Ensure project Deliverables/Timelines schedules are completed on time

Qualifications and Education Requirements

  • Minimum of 8 years progressive growth experience in Pharma/Biotech/CRO setting
  • Minimum 5 years of recent Oncology trials data management experience
  • Minimum 5 years of experience using clinical data management systems including EDC products (e.g. RAVE, Inform, BioClinica, etc.)
  • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
  • Proficiency in Microsoft Office tools
  • Strong interpersonal skills
  • Demonstrated capability of working on multiple projects simultaneously
  • Ability to complete deliverables on time and adjust priorities in a fast-paced environment
  • Ability to work independently as well as collaboratively in a team environment
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise
  • Bachelor’s degree or equivalent experience required

Join our Team

Local candidates only please!

If you are interested, please submit a cover letter and your resume to