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
Requirements
- 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
Benefits
- 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
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
Key team members
Tomaz Trcek
Martijn van de Leur
Valdis Tocs
Inga Garliauskiene
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