22mo ago

Clinical Operations Lead

Hungary·BudapestRemoteFull-time, Permanentlead

OperationsOtherOperations ManagerHealthcareClinical Operations

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Quick Summary

Overview

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…

Technical Tools

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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.

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.

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.

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

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.

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 recruitment@alimentiv.com.

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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.