Clinical Trial Manager

Clinical Trial Manager Overview

• The Clinical Trial Manager will oversee planning, execution, and management of clinical trials remotely.
• Collaborate with cross-functional teams and external vendors to ensure timely and quality study delivery.
• Focus on maintaining compliance with regulatory requirements and established protocols.
• Support CRO transitions, ensuring continuity and efficiency in ongoing clinical trial activities.
• Engage in vendor management, tracking deliverables and addressing operational risks.
• Coordinate study startup activities, including feasibility assessments and site activations.
• Monitor enrollment and implement patient recruitment strategies effectively.
• Ensure inspection readiness of the Trial Master File and maintain accurate study information.
• Contribute to study closeout activities, ensuring compliance and data accuracy.

Clinical Trial Manager Key Responsibilities & Duties

• Manage day-to-day clinical trial operations, ensuring adherence to protocols and timelines.
• Serve as the primary operational contact for assigned studies, coordinating internal and external teams.
• Oversee vendor performance, addressing quality issues and escalating risks as needed.
• Support CRO transitions, ensuring seamless transfer of responsibilities and documentation.
• Develop and maintain study timelines, tracking milestones and managing budgets.
• Coordinate study startup activities, including site selection and regulatory document collection.
• Monitor enrollment and implement strategies for patient recruitment and retention.
• Ensure completeness and accuracy of the Trial Master File and Clinical Trial Management System.
• Manage study closeout activities, including site closure and database lock support.

Clinical Trial Manager Job Requirements

• Bachelor’s degree in life sciences, nursing, or related field required.
• Minimum 3–4 years of experience as a Clinical Trial Manager.
• Phase II and Phase III clinical trial experience is essential.
• Strong CRO oversight and vendor management skills.
• Proficiency with clinical trial systems such as CTMS, eTMF, EDC, and IRT/IWRS.
• Experience in oncology and neuroscience clinical trials preferred.
• Ability to manage study timelines and operational issues effectively.
• Hands-on experience transitioning clinical trial activities between CROs is desirable.
• Strong communication, organizational, and problem-solving skills required.