Clinical Trial Manager

Job type:
on-site
Start:
08/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
08/28/2014
Country:
flag_no USA
project ID:
766416

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Duties:
  • Direct management of Clinical Operations team(s)
  • Oversight of operational activities for CROs
  • Program-specific leadership, guidance, clinical trial management expertise, and direction to achieve results
  • Lead career planning and development activities for direct reports
  • Performance management and effective coaching and training to achieve results
  • Maintain metrics for Clinical Operations tasks and skills including processes, monitoring, and best practices
  • Track data and trends on direct report job satisfaction, retention and productivity
  • Recruit top talent and staff appropriates
  • Liase with GCP Compliance on audit issues and inspection readiness activities
  • Assess quality of work for direct reports including monitoring visits, co-monitoring or oversight visits with CROs, data quality, and data clarification form managements, protocol deviation management, and planning and coordination of investigator meetings
  • Develop Clinical Operations budget including resource needs and other functional budgets)
  • Contribute to improvement of processes, systems, and tools as well as infrastructure within Clinical Operations
  • Contribute to project clinical team meetings to provide timely and accurate operational updates, plans and recommendations
  • Contribute to the development and review of Clinical Operations SOPs
  • Provide input on clinical documents including protocols for content and accuracy
  • Participate in standardization of tools within and across Clinical Operations programs


Experience
  • At least 6 years experience in a biotech or pharmaceutical/CRO organization
  • Preferred areas of therapeutic expertise; neurology/psychiatry, orphan diseases, and oncology
  • 1- 3 years of experience managing direct reports
  • Broad knowledge and cross-functional understanding of clinical trial methodology
  • Excellent knowledge of and experience with clinical trial documentation, including monitoring requirements, regulations, and operational aspects of clinical trials
  • Extensive knowledge of Good Clinical Practices and application to the conduct of clinical studies
  • Strong Communication skills; verbal, written, and presentation
  • Demonstrated excellence in the following competency areas: Leadership, people management, teamwork and collaboration, organization, and communication
  • Financial acumen in creating and managing clinical operations budgets