Alimentiv
Healthcare Insurance • Science • Pharmaceuticals
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
201 - 500 employees
Founded 2020
⚕️ Healthcare Insurance
🔬 Science
đź’Š Pharmaceuticals
Senior Clinical Operations Lead
Job not on LinkedIn
September 9
Alimentiv
Healthcare Insurance • Science • Pharmaceuticals
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
201 - 500 employees
Founded 2020
⚕️ Healthcare Insurance
🔬 Science
đź’Š Pharmaceuticals
đź“‹ Description
• Overall oversight of regional CRAs to ensure site compliance with protocol, study plans, ICH-GCP, local regulations and timelines • Provide monitoring support visits (co-monitoring) and may perform CRA responsibilities as needed • Oversee regional startup and feasibility activities and assist in vendor management • Review visit reports for quality, compliance and appropriate site management • Manage site and country performance (recruitment, data collection, document collection, TMF review) and inform clinical project team on progress • Contribute to financial project management processes (revenue recognition, site payments, pass-through expenses) • Conduct regular global and country CRA calls and attend sponsor meetings to provide status updates • Provide operational support, guidance, training and mentoring to CRAs; ensure study-specific training documented • Conduct CRA assessment visits and act as first point of contact for CRA study questions; escalate issues as appropriate • Develop training materials, study tools and monitoring plans; implement enrollment and recruitment strategies • Prepare and present materials for Sponsor Kickoff, Investigator meetings, Site Qualification and Site Initiation Visits
🎯 Requirements
• College diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgrading • OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training • Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation • 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 • Proactive, detail oriented, task-driven and highly organized • Demonstrate critical elements of GCPs and local regulations related to clinical monitoring, IRB/EC and Investigator responsibilities • Demonstrated ability in report writing and ability to critically understand clinical research documents • Ability to handle multiple tasks to meet deadlines in a dynamic environment
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