Clinical Operations Lead

Alimentiv-2; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Education reimbursement

Cell phone allowance

Remote work allowance

Office setup allowance

Visiting program

Flexible hours

Referral incentive

Alimentiv Trust

Mentorship program

Country/region events

Job summary

Alimentiv in San Diego, CA seeks a Clinical Operations Lead to oversee regional/global projects, ensuring study deliverables and regulatory compliance. You will liaise between CRAs and the clinical project team, guiding operations, training, and oversight throughout the study.

The role covers site start-up, feasibility, recruitment strategies, monitoring, issue escalation, and documentation, shaping overall project delivery.

Qualifications

• 4–6 years of relevant clinical research experience required; 7–9 years preferred.
• Minimum 3 years of CRA experience with hands-on monitoring.
• Post-secondary certificate/diploma; a Bachelor’s degree in Health Sciences, Life Sciences, Nursing or related discipline is preferred.
• Strong understanding of ICH-GCP, local regulations, IRB/EC requirements and Investigator responsibilities.
• Experience with EDC systems and clinical research documentation.
• Excellent written and verbal communication and project coordination skills.
• SOCRA and/or ACRP certification/designation is an advantage.

Responsibilities

• Provide oversight of regional CRAs and investigator sites, ensuring compliance with study protocols and timelines.
• Conduct co-monitoring and CRA assessment visits to support performance.
• Monitor recruitment, data collection, TMF activities, and communicate progress to the team.
• Oversee site start-up and feasibility activities and vendor management as needed.
• Review monitoring visit reports for quality and compliance.
• Provide study-specific training and mentoring to CRAs.
• Participate in sponsor meetings and CRA calls with updates on progress.

Skills

Clinical monitoring

ICH-GCP

Regulatory knowledge

Communication skills

Project coordination

MS Office

EDC systems

Site management

Problem solving

Training delivery

Education

Bachelor’s degree

Health Sciences

Nursing

Tools

EDC systems

Job description

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

As a Clinical Operations Lead, you will provide clinical operations oversight for projects at a regional or global level, ensuring study deliverables, CRA activities and investigator sites are managed in accordance with the protocol, monitoring plan, ICH-GCP guidelines and applicable local regulations. You will act as a key liaison between CRAs and the clinical project team, providing operational guidance, training and oversight throughout the study.

The role will also support site start-up and feasibility, recruitment and enrolment strategies, monitoring performance, issue escalation and corrective actions, while contributing to study planning, documentation and overall project delivery.

Key Responsabilities

• Provide oversight of regional CRAs and investigator sites, ensuring compliance with study protocols, monitoring plans, ICH-GCP, local regulations and study timelines.
• Conduct co-monitoring and CRA assessment visits as required, supporting site and CRA performance and ensuring monitoring standards are maintained.
• Proactively monitor site and country performance, including recruitment, data collection, document collection and TMF activities, and communicate progress to the clinical project team.
• Oversee regional site start-up and feasibility activities and support vendor management activities where required.
• Review monitoring visit reports for quality, compliance and appropriate site management, ensuring project deliverables are completed accurately and on time.
• Serve as a key point of contact for regional CRAs, providing study-specific guidance, resolving issues and escalating matters to the Project Manager or relevant functions when appropriate.
• Provide training and mentoring to CRAs on study procedures, clinical plans, guidelines and timelines, and ensure study-specific training is completed and documented.
• Participate in Sponsor meetings and CRA calls, providing updates on country and site performance and operational progress.
• Develop and implement enrolment and recruitment strategies and create study tools, training materials, monitoring plans and other clinical operations documentation.
• Support the clinical project team with study deliverables, presentations, site management activities, protocol deviations, financial project activities and other operational objectives as required.

Skills & Qualifications

• 4–6 years of relevant clinical research experience required, with 7–9 years preferred.
• Minimum 3 years of CRA experience, with strong hands‑on understanding of clinical monitoring activities.
• Post-secondary certificate/diploma required; a Bachelor’s degree in Health Sciences, Life Sciences, Nursing or a related discipline is preferred.
• Strong understanding of ICH-GCP, local regulations, IRB/EC requirements and Investigator responsibilities as they relate to clinical monitoring.
• Experience working with EDC systems and clinical research documentation.
• Strong understanding of clinical trial processes, site management, monitoring activities and study performance metrics.
• Excellent written and verbal communication skills, with the ability to effectively communicate with CRAs, Sponsors, investigators and cross-functional teams.
• Strong organisational, interpersonal and project coordination skills, with the ability to manage multiple priorities and deadlines in a dynamic environment.
• Highly proactive, detail-oriented, task‑driven and organised, with strong problem‑solving and critical‑thinking abilities.
• Proficiency in Microsoft Office and demonstrated ability to prepare high‑quality reports, presentations and clinical research documentation.
• SoCRA and/or ACRP certification/designation is an advantage.

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

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 [e-mail].

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.