Clinical Trial Manager

CTI Clinical Trial and Consulting Services; City; Hybrid; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work opportunities

Mentoring program

Job summary

CTI Clinical Trial and Consulting Services seeks an experienced Lead CRA to manage clinical monitoring activities across projects. You will oversee CRA teams, ensure training, and act as the primary contact for Clinical Monitoring in designated projects.

The ideal candidate brings 8+ years in clinical research, hands-on leadership as a Lead CRA, and a proven ability to track KPIs and quality metrics across complex studies, while operating in a hybrid work environment.

Qualifications

• 8+ years as CRA or related experience in clinical research
• Lead CRA for at least 1 year with proven performance
• Track KPIs/metrics and maintain strong performance KPIs over time
• Senior CRA level experience with complex studies
• Experience in hospital settings, pharmaceutical company or CRO
• Fluent in English

Responsibilities

• Review scope of project and resourcing for Clinical Monitoring with Clinical Project Management.
• Plan, schedule, and implement the clinical monitoring aspects of projects.
• Define project standards with KPIs, KRIs, QTLs and additional metrics.
• Primary point of contact for Clinical Monitoring on designated projects.
• Serve as advocate for the Clinical Monitoring team with the client.
• Coordinate and oversee daily operations of the Clinical Monitoring team and training for CRAs.

Skills

Lead CRA experience

Senior CRA performance

KPI / metrics tracking

Fluent in English

Education

Bachelor's degree in allied health

Nursing diploma / RN with 2+ years clinical nursing

Job description

• 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 elevate 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 monitoring point of contact for sponsors and sites for smaller or single service projects
• Participate in Bid Defense planning and Bid Defense Meetings as requested
• Assist with other duties as assigned

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 elevate 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 monitoring point of contact for sponsors and sites for smaller or single service projects
• Participate in Bid Defense planning and Bid Defense Meetings as requested
• Assist with other duties as assigned

What You'll Bring:

• At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager
• Prior proficient performance as Lead CRA for at least 1 year
• Maintained previous role performance KPIs and metrics at fully performing or exceeds level for at least 2 years
• Demonstrated successful performance at Senior CRA level, with at least 4 of the required 8 years as CRA, of experience monitoring complex studies
• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
• Experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
• Fluent in English

About CTI

• Advance Your Career

We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.

• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact

At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.