Clinical Trial Manager

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

📋 Description

• Assess project scope and resource allocation concerning Clinical Monitoring in collaboration with Clinical Project Management.

• Strategize and execute clinical monitoring components of projects.

• Establish and enforce project-specific functional standards, objectives, expectations, KPIs, KRIs, QTLs, and additional metrics.

• Act as the main contact point and advocate for clients regarding Clinical Monitoring aspects of assigned projects.

• Organize and supervise the daily activities of Clinical Monitoring teams, including CRAs and in-house staff.

• Ensure that CRAs receive training specific to the therapeutic area and project.

• Create tools and training resources for CRAs.

• Schedule and conduct CRA meetings or calls when applicable.

• Monitor study information associated with Clinical Monitoring deliverables.

• Manage clinical monitoring metrics, visit reports, action items, query resolutions, and quality metrics.

• Supervise the review and approval of visit reports, including the escalation and resolution of site issues.

• Oversee clinical monitoring milestones and rectify any deficiencies.

• Ensure the quality and timeliness of clinical data in the eDC.

• Maintain the clinical sections of the Trial Master File in compliance with SOPs.

• Engage in clinical monitoring risk planning, mitigation strategies, action plans, escalation, and resolution.

• Ensure that clinical monitoring and site management closeout tasks are finalized.

• Mentor CRAs and provide constructive performance feedback.

• Function as a trainer/mentor for CRAs, accompanying them during training, assessments, oversight, or co-monitoring visits.

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

• Perform specific CPM tasks as agreed upon with the Line Manager.

• Review CRA timesheets and report hours that exceed the budget.

• Serve as a resource for investigative sites.

• Execute on-site or remote monitoring tasks as required, including pre-study and site initiation visits.

• Be the primary monitoring contact for sponsors and sites on smaller or single-service projects.

• Participate in Bid Defense planning and discussions.

• Assist with other delegated responsibilities.

⛳️ Requirements

• Exceptional verbal and written communication abilities.

• Strong organizational and time management skills.

• Excellent critical thinking and decision-making capabilities; proactively identify challenges and potential risks.

• Outstanding collaboration, customer service, and interpersonal abilities.

• Capacity to work independently.

• Proficient with laptop computers and software systems, including CTMS, eTMF, EDC, Microsoft Excel/PowerPoint/Word, or similar platforms.

• Ability to comprehend complex medical terminology and procedures.

• Capability to review and clarify study budgets to CRAs and CMAs.

• Proficiency in monitoring complex indications.

• In-depth knowledge of ICH/GCP and all relevant regulatory requirements.

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

• Minimum of 8 years as a CRA or relevant clinical research experience.

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

• Consistently maintained previous role performance KPIs and metrics at fully performing or exceeding levels for a minimum of 2 years.

• Proven successful performance at the Senior CRA level, with 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, or health/natural science, or an RN with an Associate's Degree, or 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 in conducting clinical research studies within a hospital environment, pharmaceutical company, or CRO.

🏝️ Benefits

• Support for career advancement, with 25% of global staff promoted annually.

• A structured mentoring program.

• Tuition reimbursement options.

• Partnerships with universities and colleges.

• A dedicated training department.

• Flexible work schedules promoting work-life balance.

• Cash bonuses awarded every year for the past decade.

• A global philanthropic program supporting employees’ community involvement.