Clinical Trial Manager

Job type:
on-site
Start:
07/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
07/13/2014
Country:
flag_no USA
project ID:
741346

Warning
This project is archived and not active any more.
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Responsibilities:
  • Manages the operational aspects of clinical trials
  • Manages the study project plan, including timeline, budget, and resources
  • Participates in study strategy development, protocol, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO interactions, including sponsor oversight of operational functional activities e.g., study management, monitoring, site management, project master files)
  • Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves study-related documents(e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
  • Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Participates in the development, review and implementation of departmental SOPs and processes
  • Recommends and implements innovative process ideas to impact clinical trials management
  • Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
  • Serves as a liaison and resource for investigational sites
  • Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function


Requirements:
  • A Bachelor degree in a science or health related field required
  • 6+ years of related clinical trial management experience
  • Experience in managing CROS, specialty labs and outside vendors
  • Experience with international trials
  • Experience with rare disease desired
  • Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
  • Must be willing to travel 20-30% of time
  • Ability to deal with time demands, incomplete information or unexpected events
  • Ability to provide clinical expertise to a clinical development in a specified product area or project
  • Must possess excellent interpersonal skills
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.