Clinical Trial Manager

CTI Clinical Trial and Consulting Services

. Review project scope and resourcing related to Clinical Monitoring with Clinical Project Management .

Posted 10/27/2026full-timeRemote • Kentucky • United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Monitoring and Project Management, with a strong focus on ICH/GCP compliance, clinical data quality, and effective team leadership. Proficient in developing training materials and mentoring CRAs while ensuring adherence to project-specific metrics and timelines.

Highest-signal resume keywords

Clinical MonitoringICH/GCP KnowledgeCRA MentoringProject ManagementClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProject ManagementData Quality OversightBudget ReviewRisk PlanningKPI DevelopmentComplex Indication MonitoringTherapeutic TrainingCRA TrainingClinical Research Experience

Soft Skills

Communication SkillsOrganizational SkillsCritical ThinkingCollaboration SkillsCustomer Service

Tools & Technologies

CTMSETMFEDCMicrosoft ExcelMicrosoft PowerPointMicrosoft Word

Industry Keywords

Clinical ResearchPharmaceuticalCROTrial Master FileRegulatory Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Review project scope and resourcing related to Clinical Monitoring with Clinical Project Management
Plan and implement clinical monitoring aspects of projects
Define and implement project-specific functional standards, goals, expectations, KPIs, KRIs, QTLs, and other metrics
Serve as primary point of contact and client advocate for Clinical Monitoring aspects of designated projects
Coordinate and oversee daily operations of Clinical Monitoring teams, including CRAs and in-house personnel
Ensure CRAs receive therapeutic and project-specific training
Develop CRA tools and training materials
Organize and conduct CRA meetings/calls when in scope
Track study information related to Clinical Monitoring deliverables
Oversee clinical monitoring metrics, visit reports, action items, query resolution, and quality metrics
Oversee visit report review and approval, including site issue escalation and resolution
Manage clinical monitoring milestones and address deficiencies
Oversee clinical data quality and timeliness in the eDC
Maintain the clinical portions of the Trial Master File in accordance with SOPs
Participate in clinical monitoring risk planning, mitigation strategies, action plans, escalation, and resolution
Ensure clinical monitoring/site management closeout activities are completed
Mentor CRAs and provide performance feedback
Serve as CRA trainer/mentor and accompany CRAs on training, assessment/oversight, or co-monitoring visits
Develop cross-functional relationships with internal and external team members
Undertake specific CPM tasks as agreed with the Line Manager
Review CRA timesheets and escalate hours exceeding budget
Serve as a resource for investigative sites
Conduct on-site or remote monitoring activities as needed, including pre-study and site initiation visits
Act as primary monitoring contact for sponsors and sites on smaller or single-service projects
Participate in Bid Defense planning and meetings
Assist with other assigned duties

Requirements

What you’ll need

Excellent verbal and written communication skills
Excellent organizational and time management skills
Excellent critical thinking and decision-making skills; proactively identify challenges and potential risks
Excellent collaboration, customer service, and interpersonal skills
Ability to work independently
Proficient in laptop computer and software systems, including CTMS, eTMF, EDC, Microsoft Excel/PowerPoint/Word, or similar systems
Ability to understand complex medical terminology and procedures
Ability to review and explain study budgets to CRA and CMAs
Ability to monitor complex indications
Expert knowledge of ICH/GCP and all applicable regulatory requirements
Ability to mentor and provide constructive feedback to lesser experienced staff
At least 8 years as CRA or other pertinent clinical research experience
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, 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 conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO

Benefits

Comp & perks

Career progression support, with 25% of global staff promoted annually
Structured mentoring program
Tuition reimbursement
University and college partnership programs
Dedicated training department
Flexible schedules supporting work-life balance
Cash bonuses provided every year for the past decade
Global philanthropic program supporting employees’ local community efforts