CenterWatch

29 days old

Senior Clinical Trial Project Manager

GlobalCare Clinical Trials, LLC
Bannockburn, Illinois

QUALIFICATIONS:

  • Desire Master's degree (science or healthcare field) or study nurse
  • At least 8-10 years of relevant experience in Biopharma industry including management of multi-center/multi-country studies
  • Fluent in English or other languages desirable
  • Successful previous/current clinical team management experience
  • International experience is preferred
  • Proficient in computer skills including MS Work and Excel
  • Excellent communication skills (written and verbal)
  • Well organized, detail-oriented, and able to multi-task
  • Positive and energetic attitude
  • Able to work independently and as a team member
  • Able to take initiative while following directives
  • Able to travel internationally, if requested

ROLES AND RESPONSIBILITIES:

  • Responsible for coordinating and managing contracted services in the support of sponsored pharmaceutical and biotech studies. May involve all phases of development and a variety of therapeutic areas.
  • Review and interpret protocols and develop ambulant care training manuals for new studies
  • Track and manage study activities to ensure compliance with contracted services, timelines and budget
  • Provide weekly status report for senior management and sponsors
  • Train and manage Country Coordinators in their roles for specific studies to ensure compliance with study requirements and applicable regulations
  • Function as a liaison between sponsor, CRO, study vendors, (e.g., central lab) and Country Coordinators to communicate services and activities
  • Respond to sponsor or investigator site queries
  • Review documents provided by Country Coordinators or ambulant care Service Providers. Ensure timely provision to the investigator sites, as applicable
  • Resolve data inconsistencies with Country Coordinators
  • Update and maintain electronic study data trackers for assigned study(ies)
  • Participate in the development and implementation of process improvement initiatives
  • Attend Investigators’ Meetings and Country Coordinator trainings, as applicable
  • Participate in and lead project teleconference calls and meetings
  • Inventory and track study supplies, as applicable, such as lab kits for home visits
  • Comply with ICH/GCP guidelines, patient data protection laws, applicable SOPs and study requirements
  • Management of Clinical Trial Associates/Clinical Trial Assistants within study team
  • Other duties as may be requested from time to time

Job Type: Full-time

Experience:

  • Clinical: 5 years (Required)

Education:

  • Bachelor's (Required)

Categories

Posted: 2018-11-15 Expires: 2018-12-15

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Senior Clinical Trial Project Manager

GlobalCare Clinical Trials, LLC
Bannockburn, Illinois

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