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.

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