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

Description:
The manager of Project Data Management within Clinical Data Management (CDM) has management responsibilities over at least one therapeutic or specialty group within CDM in support of development and commercial projects.  This position will support Early and Business Development and BioOncology.

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 Genentech 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
  • Clinical Data Management system experience (EDC experience preferred)
  • Comprehensive understanding of a clinical research department's role in drug development.
  • BA/BS and/or MA/MS in biological sciences, computer sciences or equivalent
  • 5-6 years of experience in clinical research with emphasis in CDM
  • Personnel management experience preferred.

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