Clinical Operations Lead
AlimentivBudapest, Hungary
Posted December 23, 2024
Full Time
About the Company
Alimentiv is an industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes by combining deep GI expertise, advanced medical imaging solutions, and cutting-edge precision medicine. With a global network of 5,000+ sites in over 60 countries, Alimentiv offers tailored end-to-end solutions for clinical research needs, including medical imaging, precision medicine, biomarker discovery, and histopathology. Headquartered in London, Ontario, the company supports over 70% of all IBD compounds in development, delivering efficient and impactful clinical trials.
Job Description
The Clinical Operations Lead is responsible for the clinical operations of a project within a defined regional/global level. They provide oversight of project deliverables, assigned Clinical Research Associates (CRAs) and Investigator sites, ensuring compliance with protocols, GCP guidelines, and local regulations. The COL acts as a primary liaison between CRAs and the clinical project team, offering training, assessments, and operational support.
Requirements
- College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
- Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
- Minimum of 3 years CRA experience
- Strong experience with EDC systems
- Proficient with MS Office
- Strong written and verbal communication skills
- 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.
Benefits
- Home-based working conditions
