Manager, Clinical Data Management

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

Job Description

Role and Responsibilities:

  • Participates in 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
  • Select and manage vendors and contract research organizations (CRO) including generating proposals, budgets, task orders, and timelines
  • Proactively and effectively oversees data management activities, identify and resolve issues when arise with internal and external relevant parties.
  • Manage project level coordination of CDM tasks
  • Demonstrate knowledge of hands-on effort
  • Recruit, train, lead, supervise CDM staff to ensure the efficient and effective operation of the function
  • 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
  • Direct the activities of CDM team members in order to meet project deliverable schedule and according to quality standards
  • Provide/identify training of clinical data management staff and cross-functional members where applicable
  • Supervise and provide technical support to the members of the data management in all activities related to data management.
  • Establishes operational objectives and work plans and effectively delegates assignments to subordinates as necessary
  • Ensures that budgets and schedules meet corporate objectives and timelines

Qualifications and Education Requirements

  • Minimum of 8 years progressive growth experience in Pharma/Biotech/CRO setting
  • Current leadership functional/line role with minimum 6 years of experience
  • 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.)
  • Minimum 5 years in supervision and/or management positions
  • 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
  • Strong negotiation skills with vendors and management in order to influence senior leaders regarding matters of significance to the organization
  • 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