Clinical Trial Manager

il y a 3 heures

Paris er, France BIORASI LLC Temps plein

Come join our Western Europe office

Biorasi is looking for a

Senior Manager, Clinical Operations in Europe (remote)

Overview
- Biorasi is an innovative and fast-growing global CRO that provides a full range of services
- We are headquartered in Aventura, Florida, with regional offices in Germany, India, Russia and Ukraine
- Our work culture includes: Teamwork, hands-on mentality, flexibility and open communication
- Tasks: Managing the whole clinical trial project with all resources

Your main responsibilities:

- Manage or support all clinical aspects of a study, including assessing operational feasibility; assist in managing Clinical study timelines and metrics; provide study-specific training and leadership to clinical team; prepars and present project debriefings
- Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution. Determine or contribute to the list of approved sites for selection visits. Plan or assist in allocating clinical team resources. Determine, develop and implement tracking and reporting specifications
- Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF
- Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies. Participates in the planning of quality assurance activities
- Staff Management: Support Clinical Management Team or act as functional Manager to Clinical operations staff allocated on assigned projects
- Daily interaction with the Clinical Management Team and members of the cross-functional study team
- Support study management team in selecting sites and countries
- Support the cross-functional study team as needed; frequent cross-functional interactions with internal and external personnel
- Bachelor’s degree or higher, in a scientific field preferred
- 5 years of clinical research experience with a combination of clinical monitoring, study operations, and other relevant clinical research experience
- Excellent verbal, written communication and presentation skills
- Fluent English language skills
- Strong problem solving and management skills
- Knowledge of the Project Management Processes and understanding of FDA regulations and ICH GCP requirements

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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