Overview
In this role you drive the day-to-day operations of clinical trials, ensuring compliance and timely delivery within ICH/GCP guidelines. You will serve as the primary Sponsor contact for operational issues and oversee cross-functional teams to meet study milestones. Your deep protocol and therapeutic area knowledge will shape operational plans and risk management. You join a mission-driven CRO that accelerates global development of safe therapeutics and offers flexible work options for relevant experience. You will lead and scale trial operations across Phases 1–4 in a collaborative, impact-focused environment.
Pay / Benefits
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Responsibilities
- Manage day-to-day operations of the project per contract and regulatory requirements
- Serve as primary Sponsor contact for operational issues and study deliverables
- Maintain in-depth knowledge of protocol and therapeutic area
- Provide cross-functional oversight and ensure necessary training for team
- Review and input for study protocol, edit check specs, data analysis plan, and final study report when applicable
- Develop operational project plans
- Manage risk assessment and execution
- Responsible for management of study vendors
- Manage site quality and supervise Clinical Research Associates and monitoring deliverables
Key requirements
- Bachelor’s degree in health or life science field; advanced degree preferred
- 5+ years of Clinical Trial Management experience; CRO experience preferred
- Experience in Phases 1-4 (Phases 2-3 preferred)
- Project/timeline management experience; bid defense experience preferred
- Strong leadership skills
- leadership
- cross-functional collaboration
- communication
- ICH/GCP compliance
- vendor management
- study protocol development
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