Clinical Trial Manager

CTI; City; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work opportunities

Mentoring program

Job summary

CTI seeks an experienced CRA professional to lead clinical monitoring across projects, coordinating CPM, CRAs, and training. You will define metrics, ensure data quality, and act as a key liaison with clients.

The role requires 8+ years in clinical research, leadership as a Lead CRA, and strong KPI management, with a fluency in English and a background in healthcare or nursing. Hybrid work opportunities are offered by CTI.

Qualifications

• Minimum 8 years as CRA or related clinical research experience.
• Lead CRA experience for at least 1 year.
• Maintained KPI/metric performance for 2+ years.
• Senior CRA level with 4+ years monitoring complex studies.
• Bachelor's or higher in allied health; nursing credentials acceptable.
• Experience in hospital/pharmaceutical/CRO settings.
• Fluent in English.

Responsibilities

• 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 standards, goals, KPIs, KRIs, QTLs, and metrics.
• Serve as primary contact for Clinical Monitoring on designated projects.
• Advocate for Clinical Monitoring with clients and cross-functional teams.
• Coordinate daily operations of the Clinical Monitoring team and training.
• Develop CRA tools and CRA training materials.
• Oversee MVRs, visit timelines, action items, and query resolution.
• Ensure quality of data in the eDC per monitoring plan.
• Mentor CRAs and provide performance feedback to line managers.
• May train/accompany CRAs on field visits and co-monitoring.
• Build cross-functional relationships and participate in CPM tasks as needed.

Skills

CRA experience

Lead CRA

KPIs & metrics

Fluent English

Education

Bachelor's Degree or higher in allied health

RN with Associate's Degree or 3-year Nursing Diploma

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 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

AboutCTI

• Advance Your Career

Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.

• JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• MakeaLastingImpact

AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.

PleaseNote

• WewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage
• Wewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess