Clinical Trial Manager

CTI Clinical Trial and Consulting Services • Covington, KY

11d

About The Position

The Clinical Trial Manager oversees the clinical monitoring aspects of designated clinical research projects, serving as the primary point of contact for monitoring matters and as an advocate for the Clinical Monitoring team with clients. The role coordinates Clinical Research Associates (CRAs) and in-house personnel, sets project-specific functional standards and performance expectations, ensures staff training, and oversees monitoring deliverables, metrics, milestones, and quality.

The manager provides oversight of monitoring visits and reports, clinical data in the electronic Data Capture system, and the core clinical portions of the Trial Master File. The role contributes to monitoring risk planning, mitigation, issue escalation and resolution, study closeout, and CRA mentoring and performance feedback. Depending on project needs, the manager may conduct monitoring activities, serve as a site or sponsor contact, assist with Clinical Project Management tasks, and participate in bid defense activities.

Requirements

• Excellent verbal and written communication skills.
• Excellent organizational and time-management skills.
• Excellent critical-thinking and decision-making skills, including proactive identification of challenges and potential risks.
• Excellent collaboration, customer-service, and interpersonal skills.
• Ability to work independently.
• Proficiency with laptop computers and software systems, including CTMS, eTMF, EDC, Microsoft Excel, PowerPoint, and Word, or similar systems.
• Ability to understand complex medical terminology and procedures.
• Ability to review and explain study budgets to CRAs and CMAs.
• Ability to monitor complex indications.
• Expert knowledge of ICH/GCP and applicable regulatory requirements.
• Ability to mentor others and provide constructive feedback.
• At least 8 years of experience as a CRA or other clinical research experience deemed pertinent by the hiring manager.
• At least 1 year of prior proficient performance as a Lead CRA.
• Maintained fully performing or exceeding performance KPIs and metrics in a previous role for at least 2 years.
• Demonstrated successful performance at Senior CRA level, including at least 4 of the required 8 years as a CRA monitoring complex studies.
• Bachelor's degree or higher in an allied health field such as nursing, pharmacy, health, or natural science; or RN with an Associate's degree; or a 3-year Nursing Diploma and at least 2 years of 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.

Responsibilities

• Review project scope 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, expectations, KPIs, KRIs, QTLs, and other agreed metrics with the Clinical Monitoring team.
• Serve as the primary point of contact for Clinical Monitoring aspects of designated projects and advocate for the Clinical Monitoring team with clients.
• Coordinate and oversee daily operations of the Clinical Monitoring team, including CRAs and in-house personnel, and ensure assigned CRAs receive therapeutic and project-specific training.
• Develop CRA tools and training materials, and organize and conduct CRA meetings or calls when included in project scope.
• Ensure accurate tracking of study information related to Clinical Monitoring deliverables.
• Oversee clinical monitoring metrics, including visits scheduled per the Clinical Trial Monitoring Plan, monitoring visit reports and correspondence timelines, action items, query resolution, and other quality metrics; ensure targets are met and followed up on.
• Oversee visit report review and approval, including site issue escalation and resolution; perform reviews and approvals as required by the team structure.
• Manage clinical monitoring project milestones and proactively address deficiencies.
• Oversee the quality and timeliness of clinical data in the eDC in accordance with the Clinical Trial Monitoring Plan.
• Oversee core clinical portions of the Trial Master File and ensure they are current and maintained in accordance with SOPs.
• Participate in clinical monitoring risk planning and assessment; develop mitigation strategies and action plans, and manage issue escalation and resolution.
• Ensure clinical monitoring and site management closeout activities are completed.
• Mentor CRAs as needed to support performance and productivity, and provide CRA performance feedback to line managers when requested.
• Serve as a CRA trainer or mentor and accompany CRAs on training, assessment, oversight, or co-monitoring visits as necessary.
• Develop effective cross-functional relationships with internal and external team members.
• Undertake specific Clinical Project Management tasks as agreed with the Line Manager.
• Review CRA timesheets for tracked hours exceeding budget and escalate issues to the Clinical Project Manager and CRA Line Manager.
• Serve as a contact or resource for investigative sites when required.
• Conduct on-site or remote monitoring activities as needed, including pre-study and site initiation visits during project startup.
• Act as the primary monitoring contact for sponsors and sites on smaller or single-service projects when required.
• Participate in bid defense planning and meetings as requested.
• Assist with other duties as assigned.

Benefits

• Tuition reimbursement.
• Structured mentoring program and career progression support.
• Flexible schedules and work-life balance support.
• Cash bonuses have been provided every year for the past decade.
• Dedicated training department and education programs developed in partnership with universities and colleges.
• Global philanthropic program supporting employees' efforts to improve local communities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior