About the Role
The Senior Manager will lead the planning, execution, and oversight of clinical trials, ensuring adherence to protocols, timelines, and regulatory standards while managing internal and external stakeholders.
Responsibilities
- Lead end-to-end management of clinical trials from start-up through closeout
- Develop detailed study timelines and resource plans in alignment with project goals
- Serve as primary point of contact for sponsor teams and cross-functional partners
- Oversee clinical operations activities including site selection and activation
- Ensure compliance with Good Clinical Practice and applicable regulatory requirements
- Manage relationships with clinical research organizations and other third-party vendors
- Monitor trial progress and implement corrective actions when necessary
- Prepare and review clinical trial documentation including protocols and study reports
- Collaborate with data management and biostatistics teams on database lock and analysis
- Lead risk assessment and mitigation planning for clinical study execution
- Coordinate investigator meetings and site training initiatives
- Track and report key performance indicators and study milestones
- Ensure timely collection and review of essential study documents
- Support audit and inspection readiness activities
- Contribute to process improvement initiatives within clinical operations
- Mentor junior staff and support team development
- Participate in budget forecasting and financial oversight of assigned studies
- Facilitate cross-departmental communication to align study objectives
- Review monitoring reports and ensure quality oversight of clinical sites
- Ensure patient safety and protocol adherence across trial locations
- Oversee informed consent process compliance across all sites
- Manage trial supply logistics in coordination with supply chain partners
- Support regulatory submissions by providing clinical operations inputs
- Drive adoption of innovative trial methodologies including decentralized components
- Maintain up-to-date knowledge of evolving regulatory landscapes
Compensation
Competitive salary and benefits package offered based on experience and qualifications
Work Arrangement
Hybrid work model with flexibility to work remotely and in-office as needed
Team
Part of a dedicated clinical operations team focused on advancing precision medicine through innovative trial designs
Why Join Us
- Opportunity to work on cutting-edge clinical trials that integrate biomarker-driven strategies
- Supportive environment that values innovation, collaboration, and professional growth
Travel Requirements
Up to 20% travel may be required for site visits, sponsor meetings, and team events
This position may require U.S. work authorization; sponsorship is not guaranteed and will be evaluated case by case
