Clinical Trial Manager

What You'll Do:

• Review scope of project 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, and expectations with Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon
• Primary point of contact for Clinical Monitoring aspects of designated projects
• Serve as advocate for the Clinical Monitoring team with the client
• Coordinate and oversee daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training
• Develop CRA tools and CRA training materials
• Organize and conduct CRA meetings/calls if in project scope
• Ensure accurate tracking of any relevant study information related to Clinical Monitoring deliverables
• Oversight of key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed-up on as necessary
• Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure
• Manage clinical monitoring related project milestones and proactively address deficiencies
• Oversee the quality and timeliness of clinical data in the eDC per Clinical Trial Monitoring Plan
• Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and maintained in accordance with SOPs
• Active involvement in clinical monitoring risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation, and resolution
• Ensure all clinical monitoring/site management related closeout activities are completed
• Mentor CRAs, as needed, on the Clinical Project team to ensure high performance and productivity
• Provide feedback/information on CRA performance as requested by CRA line managers
• As necessary serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits.
• Develop successful cross-functional relationships with internal and external team members.
• May be required to undertake specific CPM tasks, as agreed with Line Manager
• Ability to understand and oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager
• May serve as a contact/resource for investigative sites as required
• 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 point of 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 duties as assigned

What You'll Bring:

• At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager
• 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, of experience 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 in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
• Fluent in English

About CTI

• Advance Your Career

We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.

• Join an Award-Winning Team - Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact

At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process