Clinical Trial Manager

Location: Boston, Massachusetts Salary: competitive
Sector: Pharma & Biotech, Clinical Research, R&D, Operations Type: Contract

Clinical Trial Manager (CTM / Clinical Project Manager / Clinical Operations) - Boston (Back Bay)

A pharmaceutical company conveniently located in Boston (Back Bay) is looking for a clinical trial manager. The clinical trial manager will work closely with the head of clinical operations to ensure the successful completion of phase II and III Alzheimer's and Stroke trials.


  • Assist in the development of study execution plans and study specific working practices
  • Develops, manages, and maintains relationships with external partners
  • Provides mentoring and guidance to CRA's/CTA's
  • Oversees setup and management of CTMS and the TMF with external vendors
  • Selection of Investigative Sites
    • Liaises with vendors to ensure quality site selection
    • Tracks and provides status reports for study start-up activities
  • Vendor Management
    • Assist Study Director with vendor management (performance, quality, timelines, deliverables, costs)
    • Ensures appropriate escalation and follow-up of issues as they arise
    • Reviews and approves/scrutinizes specified costs on vendor against contract
  • Initiation and Site Start-up
    • Prepares and reviews material for investigator meeting and CRA training
    • Conducts CRA training
    • Assist in the planning of country specific investigator meetings
    • Provides CRO oversight of country regulatory approvals (e.g. CTA, MoH)
    • Provides CRO oversight for site IRB/EC approvals
    • Reviews regulatory package (essential documents - blank forms and templates for 1572's, financial disclosure, etc.)
    • Authorizes investigational product shipment to investigation sites, including (in association with Regulatory affairs) the initial shipment
    • Reviews and approves informed consent forms (e.g. site or country specific ICFs)
  • Enrollment of Subjects
    • Ensures enrollment is tracked
    • Complies and reports enrollment status to management
    • Identifies enrollment and retention issues and reports to management
  • Maintenance of Sites, Subjects, and Data
    • Provides oversight of clinical monitoring to ensure quality data
    • Reviews and approves monitoring trip reports
    • Schedules and conducts CRA meetings/Teleconferences
    • Follows up on outstanding eCRFs and data queries
    • Performs co-monitoring visits to ensure data integrity
    • Oversees resolution of study conduct issues
    • Addresses site issues found during audits
    • Compiles materials and data to support Data Safety Monitoring Board
    • Ensures ongoing reconciliation of TMF
  • Study Close Out
    • Manages and oversees study close out activities
    • Reconciles final payments to investigative sites and vendors
    • Assist with study budget reconciliation
    • Completes all archiving


  • 5+ years of clinical research experience
  • 2+ year(s) of acting as a clinical trial manager / clinical project manager
  • Able to work with minimal supervision
  • Strong communication skills both written and verbal
  • Past monitoring and vendor management experience preferred

Sthree US is acting as an Employment Business in relation to this vacancy.