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Now viewing: Clinical Trial Manager
CC
CTI Clinical Trial Services, Inc.
Clinical Trial Manager
Job Description
What You'll Do
- Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management
- Plan, schedule, and implement the clinical monitoring aspects of projects
- Define and implement project-specific functional standards, goals, and expectations with Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon
- Primary point of contact for Clinical Monitoring aspects of designated projects
- Serve as advocate for the Clinical Monitoring team with the client
- Coordinate and oversee daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training
- Develop CRA tools and CRA training materials
- Organize and conduct CRA meetings/calls if in project scope
- Ensure accurate tracking of any relevant study information related to Clinical Monitoring deliverables
- Oversight of key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed-up on as necessary
- Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure
- Manage clinical monitoring related project milestones and proactively address deficiencies
- Oversee the quality and timeliness of clinical data in the eDC per Clinical Trial Monitoring Plan
- Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and maintained in accordance with SOPs
- Active involvement in clinical monitoring risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation, and resolution
- Ensure all clinical monitoring/site management related closeout activities are completed
- Mentor CRAs, as needed, on the Clinical Project team to ensure high performance and productivity
- Provide feedback/information on CRA performance as requested by CRA line managers
- As necessary serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits.
- Develop successful cross-functional relationships with internal and external team members.
- May be required to undertake specific CPM tasks, as agreed with Line Manager
- Ability to understand and oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager
- May serve as a contact/resource for investigative sites as required
- May conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre-study and Site Initiation Visits during project startup
- May act as the primary.