Clinical Trial Manager

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Review the project's scope and resources related to Clinical Monitoring in accordance with the Clinical Project Management Plan, schedule, and execute the clinical monitoring components of projects.

• Establish and implement project-specific functional standards, objectives, and expectations with the Clinical Monitoring team, including KPIs, KRIs, QTLs, and other metrics as agreed upon.

• Act as the primary liaison for Clinical Monitoring aspects of assigned projects.

• Advocate for the Clinical Monitoring team with clients.

• Manage and supervise the daily operations of the Clinical Monitoring team, including CRAs and in-house staff.

• Ensure that assigned CRAs receive both therapeutic and project-specific training.

• Create CRA tools and training materials for CRAs.

• Organize and facilitate CRA meetings or calls if included in the project scope.

• Ensure precise tracking of any pertinent study information related to Clinical Monitoring deliverables.

• Supervise key clinical monitoring metrics, including but not limited to: visits scheduled per CTMP, Monitoring Visit Reports (MVR) and their associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics to guarantee they are met and followed up on as necessary.

• Oversee the review and approval of visit reports, including the escalation and resolution of site issues; may conduct visit report review and approval based on team structure.

• Manage clinical monitoring-related project milestones and proactively address any deficiencies.

• Ensure the quality and timeliness of clinical data in the eDC according to the Clinical Trial Monitoring Plan.

• Oversee the essential clinical sections of the Trial Master File and guarantee that they are current and maintained according to SOPs.

• Actively engage in clinical monitoring risk planning and assessment, develop mitigation strategies and associated action plans, escalate and resolve issues.

• Ensure completion of all clinical monitoring and site management-related closeout activities.

• Mentor CRAs as needed within the Clinical Project team to promote high performance and productivity.

• Provide feedback and information on CRA performance as requested by CRA line managers.

• When necessary, serve as a CRA trainer/mentor and accompany CRAs in the field for training, assessment, oversight visits, or co-monitoring visits.

• Cultivate successful cross-functional relationships with both internal and external team members.

• May be required to undertake specific CPM tasks as agreed upon with the Line Manager.

• Capable of understanding and supervising CRA timesheets for hours exceeding budgeted hours and escalate to the CPM and CRA Line Manager.

• May serve as a contact/resource for investigative sites as necessary.

• 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 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 assigned duties.

⛳️ Requirements

• Exceptional verbal and written communication skills.

• Outstanding organizational and time management capabilities.

• Strong 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 using laptop computers and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Microsoft Excel/PowerPoint/Word, or similar systems.

• Ability to comprehend complex medical terminology and procedures.

• Ability to review and explain study budgets to CRAs and CMAs.

• Capacity to monitor complex indications.

• Expert knowledge of ICH/GCP and all applicable regulatory requirements.

• Ability to mentor and provide constructive feedback to less experienced colleagues.

• Minimum of 8 years as a CRA or other relevant experience in clinical research as determined by the hiring manager.

• Prior proficient performance as a Lead CRA for at least 1 year.

• Maintained previous role performance KPIs and metrics at fully performing or exceeding level for a minimum of 2 years.

• Demonstrated successful performance at the Senior CRA level, with at least 4 of the required 8 years as a CRA, with experience monitoring complex studies.

• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science, or RN with an Associate's Degree, or 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 in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.

🏝️ Benefits

• We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward.

• We value education and training – We offer tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department.

• We value our people - We have never had a layoff in our 20-year history, promote work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade.

• Our culture is unparalleled.

• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to enhance their local communities.