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Clinical Trials Project Manager

GlobalCare Clinical Trials Bannockburn, IL
  • Posted: over a month ago
  • Full-Time
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

THIS IS NOT A HOME-BASED ROLE; THIS IS AN IN-OFFICE POSITION IN BANNOCKBURN, IL.

QUALIFICATIONS:

  • Desire Master’s degree (science or healthcare field) or study nurse
  • At least 5-7 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

GlobalCare Clinical Trials

Why Work Here?

Family-feel, team-oriented, great benefits, and lots of growth opportunities!

We are the leading global provider of ambulant health care services for clinical trials. We provide innovative, GDPR/GCP-compliant services for biopharmaceutical and medical device companies by conducting selected study visits at locations convenient and comfortable for the patient (e.g., their home, workplace) when travel to the investigator site is not practical. Our network of high skilled nurses and physicians provide blood draws, pharyngeal swabs, ECGs, study drug administration, clinical assessments, questionnaires, training and data collection.

Address

Bannockburn, IL
Bannockburn, IL
USA

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