Clinical Trial Manager

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...