Clinical Operations Lead

Alimentiv; Köln; On-site; EUR 65,000 - 80,000; Full time

Benefits offered by this job

Bonus

Flexible working conditions

Job summary

A clinical research organization is seeking a Clinical Operations Leader in Cologne, Germany. Responsibilities include overseeing project deliverables and CRAs, ensuring compliance with study protocols, and mentoring regional CRAs. The role requires a combination of education and extensive experience in clinical operations, particularly in monitoring. This position is home-based and offers flexibility for the right candidate. Strong communication skills and proficiency with EDC systems are essential.

Qualifications

• 7-9 years related experience with ongoing training and knowledge/skills upgrading.
• 4-6 years' experience with substantial ongoing job-related training.
• Health Sciences, Life Sciences or Nursing specialty preferred.

Responsibilities

• Oversee CRAs to ensure site compliance with study protocol.
• Conduct monitoring support visits as required.
• Assist in vendor management activities as necessary.
• Review visit reports for quality and compliance.

Skills

Proficient with EDC systems

Strong written and verbal communication skills

Highly organized

Detail oriented

Education

College diploma/degree

Undergraduate university degree (Bachelors or Honors)

Tools

MS Office

Job description

Overview

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associates (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project-specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation, and oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Responsibilities

• Overall oversight 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 satisfactory performance and compliance with standards
• Provide oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations)
• Oversee regional startup and feasibility activities
• Assist in vendor management activities as required per project
• Review visit reports for quality, compliance, and appropriate site management
• Ensure high quality and timely project deliverables according to project requirements and the monitoring plan
• Proactively manage site and country performance (recruitment, data collection, document collection, TMF review) and inform the clinical project team on progress
• Contribute to financial project management processes as applicable (e.g., 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

Project Liaison

• Conduct regular global CRA calls with the monitoring and site management team, and with individual/country CRAs
• Attend meetings with Study Sponsor to provide status updates on country and site progress
• Provide operational support and guidance to the monitoring team throughout the project
• Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study; ensure study-specific training requirements are completed and documented
• Serve as first point of contact for regional CRAs for study-specific questions and issues; escalate 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 CRA resources
• Conduct CRA assessment visits to assess performance against monitoring responsibilities

Study Documents and Plans

• Develop training materials and study tools for sites and CRAs, including monitoring plans
• Develop and implement enrolment and recruitment strategies with the clinical project team
• Develop presentation materials for Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls as needed; prepare presentations for Site Qualification Visits and Site Initiation Visits

Qualifications

• College diploma/degree AND 7-9 years related experience with ongoing training and knowledge/skills upgrading
• OR Undergraduate university degree (Bachelors or Honors) AND 4-6 years' experience with substantial ongoing job-related training

Other

• 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 and highly effective interpersonal and organizational skills
• Proactive, detail oriented, task-driven and highly organized
• Understanding of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities
• Demonstrated ability in report writing and critical understanding of clinical research documents
• Ability to handle multiple tasks to meet deadlines in a dynamic environment

Working Conditions

• Home-based

Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [e-mail]

We may use artificial intelligence (AI) tools to support parts of the hiring process. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are made by humans. If you would like more information about how your data is processed, please contact us.

+ Bonus