About the Role
This position leads the planning, execution, and oversight of complex clinical trials within a regulated environment, driving efficiency and quality across study timelines, budgets, and deliverables.
Responsibilities
- Lead end-to-end management of multi-phase clinical trials from start-up through closeout
- Develop and maintain detailed study timelines, budgets, and resource plans
- Serve as primary point of contact for sponsor and cross-functional teams
- Ensure adherence to protocols, regulatory requirements, and industry standards
- Oversee site selection, initiation, and performance monitoring
- Manage vendor relationships and CRO performance metrics
- Coordinate regulatory submissions and documentation readiness
- Lead risk identification and mitigation planning across trial phases
- Drive data quality and monitoring strategy implementation
- Support audit and inspection preparedness activities
- Facilitate cross-functional team meetings and decision-making forums
- Monitor study progress and report key performance indicators
- Ensure patient safety and protocol compliance throughout trial lifecycle
- Collaborate with medical and scientific teams on protocol design input
- Implement quality management systems aligned with GCP guidelines
- Manage trial documentation in compliance with regulatory standards
- Oversee informed consent process and site training materials
- Coordinate with data management and biostatistics teams for analysis readiness
- Lead trial-specific training for internal and external stakeholders
- Support budget forecasting and financial tracking for assigned studies
- Ensure diversity and inclusion goals are integrated into recruitment plans
- Promote continuous process improvement across trial operations
- Maintain up-to-date knowledge of evolving regulatory landscapes
- Escalate critical issues to senior leadership with resolution recommendations
- Foster a culture of accountability, transparency, and collaboration
Compensation
Competitive salary and performance-based incentives commensurate with experience
Work Arrangement
Hybrid work model with flexibility for remote operations
Team
Part of a specialized clinical operations unit within a precision medicine-focused organization
Why This Role Matters
This position plays a pivotal role in advancing targeted therapies by ensuring clinical trials are executed with precision, compliance, and operational rigor, directly contributing to the development of innovative treatments for complex diseases.
Our Commitment to Diversity
We actively foster an inclusive workplace and encourage participation from individuals across diverse backgrounds, perspectives, and experiences to strengthen our approach to clinical research.
Not available for this position
