Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team.
Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.
The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.
Project Oversight
- Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
- Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
- May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality, compliance and appropriate site management.
- Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
- Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
- Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
- May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.
Project Liaison
- Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
- Attend meetings with Study Sponsor to provide status updates on country and site progress
- Provide operational support and guidance to the monitoring team throughout project.
- Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
- First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
- Support line managers by providing status updates on utilization and performance of CRAs.
- Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
- Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.
Study Documents and Plans
- Develop training materials and study tools for sites and CRAs, including monitoring plans.
- Develop and implement enrolment and recruitment strategies together with clinical project team.
- Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.
Qualifications
- College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
OR
- Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
Other
- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
- Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
- Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Working Conditions
$78,000 - $130,000 a year
+ Bonus
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [email protected]
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website.
If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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.
- Minimum of 3 years of hands-on CRA experience and 2 years of Clinical Operations Lead (COL) or equivalent clinical operations leadership experience.
- 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 regulations.
- Demonstrated experience providing operational oversight across clinical studies, including monitoring, site management, study start-up and study-level deliverables.
- Strong experience reviewing monitoring reports, clinical research documentation, protocol deviations, study metrics and operational risks.
- Experience working with EDC systems and proficiency with Microsoft Office applications.
- Strong written and verbal communication skills with the ability to work effectively with CRAs, COLs, project teams, Sponsors and other cross-functional stakeholders.
- Highly organised and proactive, with strong attention to detail and the ability to prioritise multiple deliverables and meet deadlines in a dynamic environment.
- Strong leadership, mentoring, problem-solving and interpersonal skills, with the ability to provide guidance and influence stakeholders without formal direct-line authority.
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].
Salary
$78,000 - $130,000 a year
+ Bonus
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.