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United States
Onsite
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Sr. Clinical Operations Lead based in the United States.
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.
Provide regional and/or global clinical operations oversight across assigned clinical trials, ensuring compliance with study protocols, Monitoring Plans, ICH-GCP guidelines, applicable regulations, and project timelines.
Lead and support Clinical Operations Leads (COLs) and Clinical Research Associates (CRAs), providing study-specific guidance, training, mentoring, and operational direction throughout the clinical trial lifecycle.
Oversee monitoring and site management deliverables, including visit schedules and reports, recruitment progress, essential document collection, protocol deviations, and adherence to Monitoring Plans.
Lead and contribute to country and site feasibility assessments, selection, and start-up activities, providing operational input into country and site strategies.
Act as a key point of coordination between monitoring teams, Clinical Project Management, cross-functional stakeholders, and Sponsors, escalating operational risks and supporting the implementation of corrective actions.
Develop and maintain study-specific operational documentation and resources, including Monitoring Plans, CRA and site training materials, study tools, and recruitment strategies.
Review monitoring visit reports, study documentation, and performance metrics to ensure quality, consistency, effective site management, and timely study delivery.
Lead CRA and COL meetings and represent Monitoring and Site Management in Sponsor meetings, study kick-offs, Investigator Meetings, and other project discussions as required.
Support project and monitoring budget oversight, including resource planning, visit forecasting, site payments, pass-through expenses, and other financial activities where applicable.
Contribute to departmental and organizational initiatives, support business development and Sponsor-related activities when needed, and mentor clinical operations colleagues.
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.
Annual salary ranging from $86,000 to $143,000, plus bonus.
Education reimbursement program for full-time employees.
Monthly cell phone and remote work allowance, subject to role eligibility.
One-time office setup allowance, which may be used for equipment and furniture such as monitors, printers, scanners, and office furniture.
Working While Visiting program, allowing eligible employees to work while visiting another location for up to four weeks per year.
Flexible Summer Hours program from May through September.
Employee referral incentive program.
Eligibility to become a beneficiary of the employee trust after one year of full-time employment, with permanent membership after five years.
Optional formal mentorship program.
Regional and country-level annual in-person social events.
Leadership development programs for people managers, aligned with seniority.
Additional optional social and employee engagement initiatives.
Additional benefits may be available depending on the country of employment and applicable local policies and eligibility.