Clinical Trial Manager

Location: Milan, Italy

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I am working with a leading CRO who is continuing to add senior-level directors and established project managers to join their clinical management team.

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I am currently seeking a Clinical Trial Manager (CTM) based in Belgium, Germany, Italy and Spain with 5+ years’ experience working with a CRO based at home.

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Responsibilities:

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations

• Serve as primary sponsor contact for operational project-specific issues and study deliverables

• Maintain in depth knowledge of protocol, therapeutic area, and indication

• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided

• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable

• Develop operational project plans

• Manage risk assessment and execution

• Responsible for management of study vendor

• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

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Qualifications:

• Minimum Bachelor’s degree in a health-related field; advanced degree in a health-related field preferred

• Experience in Phases 1-4; Phases 2-3 preferred

• 5+ years as a project/clinical trial manager within a CRO

• Management of overall project timeline

• Bid defence experience preferred

• Strong leadership skills

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If you are interested in this opportunity, please don’t hesitate to reach out to me +44 1273 952187, alternatively you can contact me via email roxanna.keshavarz@rbwconsulting.com

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Salary: On application