About the Role
The Clinical Trial Manager will lead the operational aspects of clinical studies, managing cross-functional collaboration, vendor oversight, and trial execution to support timely and compliant delivery of clinical development objectives.
Responsibilities
- Lead the planning and execution of clinical trial activities across multiple study phases
- Develop and manage study timelines, milestones, and deliverables in collaboration with cross-functional teams
- Serve as primary point of contact for clinical operations across internal and external stakeholders
- Oversee contract and budget negotiations with clinical research organizations and vendors
- Ensure clinical trial documentation is complete, accurate, and audit-ready
- Monitor trial progress against operational metrics and implement corrective actions when needed
- Coordinate investigator selection, site initiation, and trial conduct activities
- Manage clinical supply logistics and drug accountability processes
- Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements
- Support the development of clinical study protocols and related materials
- Lead trial master file maintenance and inspection readiness efforts
- Facilitate internal and external study team meetings with clear action tracking
- Oversee data collection processes and collaborate with data management teams
- Assist in safety reporting and adverse event follow-up coordination
- Prepare and review clinical trial reports and study summaries
- Drive risk management planning and mitigation strategies for clinical studies
- Ensure patient recruitment strategies are implemented and progress is tracked
- Maintain up-to-date knowledge of applicable regulations and industry standards
- Collaborate with regulatory affairs to support submission readiness
- Support process improvement initiatives within clinical operations
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Part of the clinical development team within a biopharmaceutical organization
About the Company
Focused on developing innovative therapies for cardiorenal diseases, the organization operates with a mission-driven approach to improve patient outcomes through science and clinical excellence.
Culture and Values
Emphasizes collaboration, accountability, and integrity in all aspects of clinical development and patient-centered research.
May offer sponsorship for qualified candidates based on business needs
