Sr. Clinical Operations Lead

As a Senior Clinical Operations Lead, you will provide regional and global operational leadership across clinical trials, ensuring high-quality monitoring and site management throughout the study lifecycle. You will work closely with Clinical Project Management, Clinical Operations Leads, Clinical Research Associates, investigative sites, Sponsors, and cross-functional teams. Your responsibilities will span country and site start-up, monitoring oversight, recruitment, study documentation, performance management, and risk mitigation. You will guide and mentor clinical operations colleagues while ensuring that study activities meet protocol requirements, ICH-GCP standards, applicable regulations, and project timelines. The role offers an opportunity to influence complex clinical programs, strengthen operational delivery, and contribute to research that advances treatments for gastrointestinal diseases. You will also support Sponsor engagement and broader clinical operations initiatives in a collaborative, international environment.

• Approximately 7–9 years of relevant clinical research experience; 10 or more years is preferred.

• At least 3 years of hands-on Clinical Research Associate experience and 2 years in a Clinical Operations Lead role or equivalent clinical operations leadership position.

• Bachelor's degree in a relevant discipline preferred; an equivalent combination of education and relevant clinical research experience may be considered.

• Strong knowledge of ICH-GCP, clinical monitoring requirements, IRB/EC processes, investigator responsibilities, and applicable local regulatory requirements.

• Demonstrated experience providing operational oversight across clinical studies, including monitoring, site management, study start-up, and study-level deliverables.

• Proven ability to review and assess monitoring reports, clinical research documentation, protocol deviations, study performance metrics, and operational risks.

• Experience working with Electronic Data Capture (EDC) systems and proficiency in Microsoft Office applications.

• Excellent written and verbal communication skills, with the ability to collaborate effectively with CRAs, COLs, project teams, Sponsors, and other cross-functional stakeholders.

• Strong organizational and planning skills, with attention to detail and the ability to prioritize multiple deliverables and meet deadlines in a dynamic environment.

• Demonstrated leadership, mentoring, problem-solving, and interpersonal skills, including the ability to guide colleagues and influence stakeholders without formal direct-line authority.

• Proactive, adaptable, and comfortable taking ownership of operational challenges while maintaining high standards of quality and compliance.