Sr. Clinical Operations Lead

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.

If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!

Job Overview

The Senior Clinical Operations Lead (Sr COL) provides clinical operations leadership and oversight for regional and global clinical trials, ensuring high-quality delivery across monitoring and site management activities.

Working closely with Clinical Project Management, Clinical Operations Leads (COLs), Clinical Research Associates (CRAs), investigative sites and cross-functional teams, the Sr COL is responsible for ensuring study activities are delivered in accordance with the protocol, Monitoring Plan, ICH-GCP, applicable regulations and project timelines.

This role provides operational leadership across the study lifecycle, including country and site start-up, monitoring oversight, enrolment and recruitment, CRA/COL guidance and training, study documentation, performance metrics, issue escalation and corrective actions. The Sr COL may also represent Monitoring & Site Management in Sponsor meetings and provide broader trial management support as required.

Key Responsabilities

• Provide regional and/or global clinical operations oversight across assigned studies, ensuring compliance with study protocols, Monitoring Plans, ICH-GCP, applicable regulations and project timelines.

• Lead and oversee Clinical Operations Leads (COLs) and CRAs, providing study-specific guidance, training, mentoring and operational support throughout the project lifecycle.

• Oversee key monitoring and site management deliverables, including monitoring visit schedules and reports, recruitment progress, essential document collection, protocol deviations and compliance with the Monitoring Plan.

• Lead and support country and site feasibility, selection and start-up activities, providing Monitoring & Site Management input into country and site strategies.

• Serve as a key liaison between the monitoring team, Clinical Project Management, cross-functional study teams and Sponsors, escalating risks and issues and supporting appropriate corrective actions.

• Develop and maintain study-specific operational documentation and tools, including Monitoring Plans, CRA/site training materials, study tools and enrolment and recruitment strategies.

• Review monitoring visit reports and study performance metrics to ensure quality, consistency, appropriate site management and timely delivery.

• Lead CRA/COL meetings and represent Monitoring & Site Management during Sponsor meetings, study kick-offs, Investigator Meetings and other project discussions as required.

• Support project and monitoring budget oversight, including monitoring resource planning, visit forecasts, site payments, pass-through expenses and other project financial activities as applicable.

• Contribute to departmental and company initiatives, support business development and Sponsor activities where required, and provide mentorship to COLs and other clinical operations colleagues.

Skills & Qualifications

Approximately 7–9 years of relevant clinical research experience; 10+ years is preferred.

What We Offer

In addition, as an Alimentiv Employee, you’re also eligible for the following programs:

• Education Reimbursement program for full-time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September
• Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!

Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.

Our Services

• End-to-end GI clinical trial services, from protocol design through submission support
• Central medical imaging management and endoscopic reading
• Precision medicine and biomarker solutions
• Real-world evidence and clinical consulting
• Histopathology and lab services through AcelaBio

How to Apply

To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English.

Equal Opportunity and Accessibility

Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [email protected].

Stay Alert to Recruitment Scams

Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process.

Official communication will only come from company email addresses containing "@alimentiv.com". If you are contacted about an open job at Alimentiv, please verify the domain of the sender's email address and confirm that you are being asked to apply on this website. If something doesn't feel right, we encourage you to verify before responding. If you believe you have been the victim of a phishing scam, please contact your local government cyber authority to report it.