Clinical Trial Manager at craresources
Clinical Trial Manager (Anywhere US)
- Category: CTM
- Job #: 10637
- Location: US, Remote
- Job Type: Permanent
- Rate / Salary Range: Competitive Compensation and Benefits
One of our sponsor partners is looking for several experienced Clinical Trial Managers to manage Oncology Studies. The main focus of each manager is to ensure the success of the clinical monitoring team as well as the monitoring tasks throughout each trial. This sponsor is offering a very competitive salary and benefits package for these permanent positions.
- 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.
- 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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