Clinical Trial Manager

🔥 43 minutes ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• 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

• 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

• 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