Connecting...

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.

Responsibilities:

  • 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

Qualifications:

  • 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.