Job OverviewThe 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 OfferIn 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 ApplyTo 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.
Salary$78,000 - $130,000 a year
+ Bonus
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