Clinical Trial Manager

Join The CTI Team • Covington, KY

10d

About The Position

The Clinical Trial Manager oversees the Clinical Monitoring aspects of designated clinical research projects. The role reviews project scope and resourcing, develops and implements project-specific standards and expectations, and serves as the primary point of contact and advocate for Clinical Monitoring with clients. It coordinates the daily work of CRAs and in-house personnel, ensures appropriate training, and monitors project deliverables, metrics, milestones, data quality, and documentation. The position also supports risk planning, issue escalation and resolution, site and sponsor communications, CRA mentoring, and monitoring activities as needed. Additional CPM tasks and other duties may be assigned.

Requirements

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

Responsibilities

• Review project scope and Clinical Monitoring resourcing in relation to the Clinical Project Management Plan; plan and implement project monitoring activities.
• 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 contact for Clinical Monitoring aspects of designated projects and advocate for the team with clients.
• Coordinate and oversee daily operations of CRAs and in-house personnel, and ensure assigned CRAs receive therapeutic and project-specific training.
• Develop CRA tools and training materials; organize and conduct CRA meetings or calls when included in project scope.
• Track study information related to Clinical Monitoring deliverables and oversee monitoring metrics, including scheduled visits, visit report and correspondence timelines, action items, query resolution, and quality metrics.
• Oversee visit report review and approval, site issue escalation and resolution; conduct review and approval as required by 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 according to SOPs.
• Participate in clinical monitoring risk planning and assessment; develop mitigation strategies and action plans, and manage issue escalation and resolution.
• Ensure completion of clinical monitoring and site management closeout activities.
• Mentor CRAs on the Clinical Project team and provide performance feedback to CRA line managers when requested.
• Serve as a CRA trainer or mentor and accompany CRAs on training, assessment/oversight, or co-monitoring visits as needed.
• Develop effective cross-functional relationships with internal and external team members.
• Undertake specific CPM tasks as agreed with the Line Manager.
• Review CRA timesheets for tracked hours that exceed budget and escalate concerns to the CPM 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.
• Serve as the primary monitoring contact for sponsors and sites on smaller or single-service projects when applicable.
• Participate in bid defense planning and meetings as requested, and perform other assigned duties.

Benefits

• Tuition reimbursement.
• Structured mentoring program.
• Flexible schedules to support work-life balance.
• Cash bonuses have been provided every year for the past decade.
• Career progression and promotion opportunities; the posting states 25% of global staff is promoted annually.
• Training resources, including a dedicated training department and education programs developed 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