About the Role
This role leads clinical operations for global trials, managing study timelines, vendor relationships, and site performance to ensure high-quality data delivery within regulatory standards.
Responsibilities
- Lead the planning and execution of clinical trials from start-up through closeout
- Oversee vendor selection and management, including CROs and other third parties
- Develop and manage clinical study timelines and operational budgets
- Ensure adherence to protocols, GCP guidelines, and regulatory requirements
- Collaborate with cross-functional teams to align study objectives
- Monitor site performance and support recruitment strategies
- Review and approve operational documents such as study plans and trackers
- Serve as primary point of contact for operational issues across studies
- Conduct risk assessments and implement mitigation strategies
- Support the development of study-specific training materials for sites
- Track and report key performance indicators for clinical operations
- Ensure data integrity through effective monitoring oversight
- Participate in investigator meetings and site initiation activities
- Manage central and local monitoring strategies
- Coordinate with regulatory teams for submission readiness
- Oversee the maintenance of trial master files
- Drive process improvements across clinical operations functions
- Support audit and inspection readiness activities
- Provide input into protocol and case report form development
- Ensure patient safety and protocol compliance throughout study conduct
- Lead team huddles and operational meetings with internal and external stakeholders
- Evaluate vendor performance and recommend improvements
- Assist in the development of standard operating procedures
- Promote a culture of quality and compliance across teams
- Contribute to lessons learned sessions post-study completion
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility based on location and role requirements
Team
Part of a dedicated clinical development team focused on advancing gastrointestinal therapies
Why Join Us
- Opportunity to work on innovative gastrointestinal therapies with a patient-focused mission
- Collaborative environment that values expertise and professional growth
Our Commitment to Diversity
- We value inclusivity and are committed to building a diverse and equitable workplace
- All qualified applicants will receive consideration without regard to background or identity
Not available for this position
