Alimentiv is hiring a
Clinical Operations Lead, Remote - Germany

Summary

The job is for a Clinical Operations Lead role in a clinical research project. The COL will oversee the operations of the project, provide oversight to assigned CRAs and investigator sites, develop study tools, review visit reports, and support other objectives for clinical operations. The COL will also act as a primary liaison between the CRAs and the clinical project team.

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

Responsibilities

• Overall oversight of (a group of) regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
• Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above
• Oversee regional startup and feasibility activities
• Assist in vendor management activities as required per project
• Perform review of visit reports for quality, compliance and appropriate site management
• Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan
• Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress
• Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review
• May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis
• Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
• Attend meetings with Study Sponsor to provide status updates on country and site progress
• Provide operational support and guidance to the monitoring team throughout project
• Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented
• First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate
• Support line managers by providing status updates on utilization and performance of CRAs
• Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project
• Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities

Preferred Qualifications

• Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation
• Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills

Benefits

• Home-based
• ���57,000 - €94,000 a year + Bonus