Clinical Trial Manager
About The Position
This is a contract position (initial 8-month term with potential extension). The Contract Clinical Trial Manager (CTM) will serve as the sponsor-side operational study lead, responsible for day-to-day execution and oversight of clinical trial activities during study start-up, activation, and enrollment phases of the clinical trial. This role will act as an operational interface with CRO partners and internal cross-functional teams, ensuring timelines, budgets, quality standards, and compliance obligations are met. The CTM will manage study governance processes including risk management, decision logs, meeting cadence, and financial tracking, while supporting TMF oversight and clinical quality system activities. The CTM will report to the Senior Clinical Operations leadership and work closely with the CRO, Monitoring Manager, CRAs, Legal/Finance, QA, and external vendors.
Requirements
- Bachelor's degree in life sciences or equivalent training/experience
- Minimum of 7+ years of clinical research experience within medical device industry, biotechnology, or pharmaceutical industry
- At least 3-5 years of clinical trial management or study coordination experience
- Experience supporting clinical study budgets, accrual forecasting, and vendor oversight required
- Demonstrated knowledge of FDA regulations, ISO/ICH-GCP, and applicable clinical research standards
- Strong understanding of clinical trial lifecycle from study start-up through close-out
- Experience maintaining risk registers, action logs, and project timelines
- Familiarity with clinical trial budgeting, accrual tracking, and invoice reconciliation
- Ability to analyze operational metrics and identify trends
- Strong organizational and documentation skills
- Excellent written and verbal communication skills
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with EDC/TMF systems
- Ability to manage multiple priorities in a fast paced, small company environment
- Demonstrated ability to work independently while escalating appropriately
Nice To Haves
- Experience working within a sponsor/CRO hybrid operating model preferred
- Medical device clinical trial experience strongly preferred
Responsibilities
- Study Execution & Project Management
- Lead day-to-day operational management of assigned clinical study(s) under the direction of the Sr. Clinical Operations Manager
- Develop and maintain detailed study timelines and project trackers
- Coordinate cross-functional study team meetings and maintain action item logs
- Maintain and actively manage the study risk log with mitigation plans and decision log; escalate significant risks appropriately
- Track study milestones to ensure adherence to approved timelines
- Support development and execution of operational plans while ensuring compliance with current regulatory guidance and GCPs
- Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports, and annual reports
- Serve as operational liaison with CRO
- Monitor CRO performance metrics and escalate concerns to the Sr. Clinical Operations Manager
- Budget & Financial Oversight
- Track study budget, accruals, and financial forecasts
- Support invoice review and reconciliation
- Coordinate CTA/CTA Amendments in partnership with legal and finance as needed
- Ensure financial alignment between scope, contracts, and study execution
- Monitoring & Site Integration
- Review monitoring reports as needed, identify trends, and escalate issues appropriately
- Conduct site level training as needed
- Quality & Compliance
- Ensure study activities are conducted in compliance with applicable regulations, GCP, and company SOPs
- Perform sponsor-level TMF oversight reviews (in collaboration with CRO)
- Provide support in the development of new clinical processes and SOPs as needed
- Support inspection readiness efforts through documentation tracking and quality review
- Ensure essential documents are filed appropriately and timely
- Upload sponsor quality documents into the Quality Management System (QMS)
- Prepare routine study status updates and dashboards for internal stakeholders
- Support preparation of clinical study reports, clinical evaluation reports, and regulatory submission documentation as requested
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What This Job Offers
Career Level
Mid Level
Number of Employees
1-10 employees
