Senior Clinical Trial Manager

Overview

• Lead the planning and execution of late-stage cardiovascular clinical trials, ensuring quality and compliance.
• Collaborate with cross-functional teams and external vendors to achieve study objectives efficiently.
• Provide strategic oversight to maintain inspection-ready documentation throughout the study lifecycle.
• Contribute to operational excellence and innovative clinical science in cardiovascular medicine.
• Utilize strong communication and stakeholder management skills to drive project success.
• Ensure adherence to ICH-GCP guidelines and global regulatory requirements.
• Support site selection and activation activities to optimize enrollment and engagement.
• Enhance program-level planning, process improvement, and best practice initiatives.

Key Responsibilities & Duties

• Manage clinical trial operations from startup through database lock and closeout.
• Serve as the primary contact for stakeholders, providing leadership to CROs and vendors.
• Oversee CRO/vendor performance, ensuring deliverables meet contractual scope and quality metrics.
• Develop protocol-related materials, including CRFs, ICFs, and study manuals.
• Monitor trial progress, assess risks, and implement mitigation strategies.
• Maintain accurate and complete TMF documentation throughout the study lifecycle.
• Manage study budgets, timelines, and resource plans effectively.
• Lead study team meetings and communicate key decisions across functional lines.

Job Requirements

• Bachelor’s degree in life sciences, nursing, or healthcare-related discipline (advanced degree preferred).
• Minimum of 7 years of clinical research experience, including 3 years in clinical trial management.
• Strong knowledge of ICH-GCP and global regulatory requirements.
• Proven success managing CROs, vendors, budgets, and global phase II–III studies.
• Excellent organizational and communication skills with a proactive mindset.
• Proficiency in clinical systems such as EDC, IRT, eTMF, and CTMS.
• Ability to manage multiple priorities in a dynamic environment.
• Willingness to travel as required (approximately 10–15%).