Job Description
Join our global team as Clinical Operations Lead.
Clinical Operations Lead is responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.
Position in any EU country. All CV’s must be submitted in English language.
Responsibilities:
Oversight of (a group of) study CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
Monitoring support visits (Accompanied site visits), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards
Develop training materials and study tools for sites and CRAs, including monitoring plans
Develop and implement enrolment and recruitment strategies together with clinical project team
Support clinical project team by providing oversight of study deliverables related to other functions (e.g. Data Management, TMF Operations, etc.)
Proactive management of site and country performance (recruitment, data collection, document collection, TMF review, timely update of Biomapas/sponsor CTMS by the study CRAs etc.) and inform clinical project team on progress
Oversee regional startup and feasibility activities
Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study
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
Bachelor’s or Master’s Degree in Medicine, Pharmacy or Life science
3 years experience in Clinical Lead role
Fluent written and spoken English language
Good coordination skills
Attention to detail, time-management and problem-solving skills
Strong organization and analytical skills
Professional growth and career opportunities
International team and environment
Bonus based on annual performance
Personal accident and business trip insurance
Additional health insurance
Remote/home based
Complimentary health and wellness benefits, such as influenza vaccines
Rewarding referral policy
Workplace establishment allowance (fully remote)
Team building, global meetings, B active events
