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Title:Manager, Clinical Data Management
Salary:Open
Experience:5-6
Location:CA - South San Francisco

Description:
The manager of Study Configuration within Clinical Data Management (CDM) has management responsibility for CDM activities related to study initiation, including the development of paper case report forms (CRFs), electronic CRFs (eCRFs), EDC and paper-based clinical study databases and edit check programming.

Responsibilities:
  • Coaching, supporting, managing and leading staff
  • Tracking and managing progress on group deliverables
  • Reviewing and approving group deliverables
  • Working collaboratively with management colleagues in other functional areas
  • Planning, allocating, and prioritizing CDM resources
  • Contributing to development of CDM budgets
  • Establishing goals, expectations, and accountabilities for staff
  • Providing feedback, evaluation, and recognition of staff performance
  • Recruiting and hiring new permanent and contract staff
  • Ensuring that staff receive appropriate training
  • Contributing to the development and delivery of CDM-specific goals in support of DATA Group, Development, and corporate goals
  • Leading the evaluation, development, and implementation of new processes and standards within Development and CDM
  • Representing CDM in company and industry-wide activities and initiatives.

Requirements:
  • Demonstrated strong leadership, interpersonal, communication and problem-solving skills
  • Excellent organizational skills, strong project planning and management skills
  • Demonstrated ability to effectively collaborate and build constructive relationships across functional boundaries
  • Knowledge of GCPs, other FDA regulations related to CDM and industry conventions (e.g., SCDM GCDMPs, CDISC)
  • Comprehensive understanding of the conceptual basis for CDM conventions, standards and processes
  • Significant CDM system experience (EDC experience preferred)
  • Comprehensive understanding of a clinical research departments role in drug development.
  • BA/BS and/or MA/MS in computer sciences or equivalent
    5-6 years of experience in clinical research with emphasis in CDM
  • Personnel management and programming/DBA experience preferred.

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