Biopharmaceuticals - Clinical Trial Manager (m-w)

Vollzeit | 5 Monate
Diese Position ist möglicherweise abgelaufen!




Biopharmaceuticals - Clinical Trial Manager (m-w)
BioPharma SZ
Oberhaching (near Munich)
Hexal AG
Research & Development
Full Time
• Responsible for sponsor oversight of clinical monitoring activities in international studies outsourced to CROs
• Support the Clinical Trial Lead (CTL) in the development of operational trial execution plans and processes
• Review and approval of CRO processes and study specific plans including the clinical Monitoring Plan of the CRO
• Develop and implement the sponsor Site Management Oversight Plan
• Serve as main sponsor contact to the international clinical monitoring team of the CRO
• Train the clinical monitoring team of the CRO on the study protocol and key trial elements together with CTL
• Review and approve country specific Informed Consent Forms
• Approve clinical study sites for study participation
• Oversee clinical monitoring activities according to the Site Management Oversight Plan to identify quality/compliance issues and ensure regulatory compliance, including review of CRO monitoring visit reports
• Conduct co-monitoring visits with the CRO field monitors
• Provide governance on the country and site level TMFs maintained by the CRO, and ensure complete and accurate study documentation
• Report the study status on country and site level in clinical trial team meetings and escalate deficiencies with regard to quality and timelines
• Assist with preparation, conduct and follow up of audits and regulatory inspections
• Bachelor’s degree or equivalent qualification in life science/healthcare, Master degree is preferred
• >5 years pharmaceutical industry experience with 3-5 years strong experience in clinical research in a field monitor role and in a role overseeing clinical trials
• Very good communication skills and ability to work in an international matrix environment
• Ability to work under pressure
• Excellent negotiation and conflict resolution skills

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