Clinical Operations Lead
Employer · Alimentiv
Health services manager
Other health professional
R&D managerFull-timeBudapest
As a Clinical Operations Lead at Alimentiv, 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.
Tasks
- 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
- Proactively monitor site and country performance, including recruitment, data collection, document collection and TMF activities
- Oversee regional site start-up and feasibility activities and support vendor management activities
- Review monitoring visit reports for quality, compliance and appropriate site management
- Serve as a key point of contact for regional CRAs, providing study-specific guidance and resolving issues
- Provide training and mentoring to CRAs on study procedures, clinical plans, guidelines and timelines
- Participate in Sponsor meetings and CRA calls
- Develop and implement enrolment and recruitment strategies and create study tools and training materials
- Support the clinical project team with study deliverables, presentations, site management activities, and protocol deviations
Conditions & benefits
Education Reimbursement programAvailable for full-time employeesMonthly Cell Phone and Remote Work AllowanceDependent on role eligibilityOne time office setup allowanceCan be used to purchase a scanner/printer, extra monitor, office furniture, etc.Working while visiting programUp to 4 weeks per yearFlexible Summer Hours ProgramFrom May to SeptemberEmployee referral incentiveRecognition for referring great peopleAlimentiv TrustFull-time employees become beneficiaries after one year and permanent members after 5 years
Requirements
- 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
- Highly proactive, detail-oriented, task-driven and organised
- Proficiency in Microsoft Office