Clinical Trial Manager (US)

Category: CTM
Job #: 10607
Location: US
Job Type: Permanent
Rate / Salary Range: Competitive Compensation and Benefits

One of our sponsor partners is looking for an experienced Clinical Trial Manager to manage Oncology Studies.  This sponsor is offering a very competitive salary and benefits package for this permanent position.

Job Responsibilities:
  • Participate in site identification, recruitment, and selection.
  • Manage regulatory document collection and review.
  • Overall scheduling and management of all site visits.
  • Develop site/monitoring tools and training materials.
  • Ensure CRAs assigned receive therapeutic and project-specific training.
  • Define and implement functional standards, goals, and expectations with the clinical monitoring team.
  • Serve as CRA mentor and perform accompanied field assessment visits as required.
  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
  • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team to identify solutions.
  • Set and enforce project timelines with the assigned study team.
  • Coordinate remote review of clinical data within EDC system.
  • Assure that appropriate SOPs are followed.
  • Oversee monitoring visit schedule to ensure compliance with the frequency set forth in the monitoring plan.
  • Review and approve trip reports and follow-up letters within the required time-frame.
  • Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
  • Ensure all project documentation is appropriately filed per SOPs.
  • Schedule and manage weekly CRA project team meetings.
  • Review and approve CRA travel expenses and timesheets.
  • Attend and provide information at monthly projections meetings.
  • Attend and provide information at weekly teleconferences/team meetings.
  • Assist PM in preparation of audit responses, as appropriate.
  • Assist PM in the review of project budgets, monitoring costs, potential overruns and propose/implement cost-effective solutions.
Job Qualifications:
  • Minimum 4 years of experience as a fully dedicated regional, home-based, field monitor for a CRO or Pharma
  • Minimum 2-3 years of Clinical Trial Management experience
  • Experience in managing the coordination and daily operations of a clinical monitoring team
  • Experience working in Oncology studies is a plus

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