Clinical Trial Specialist (m/f) - Biopharmaceuticals

Vollzeit | Oberhaching, BAYERN | etwa ein Jahr
Diese Position ist möglicherweise abgelaufen!




Clinical Trial Specialist (m/f) - Biopharmaceuticals
BioPharma SZ
Oberhaching (near Munich)
Hexal AG
Research & Development
Full Time
• Support the clinical study lead in day to day business
• Set up, maintenance, filing, and archiving of the study documentation; maintenance of Trial Master File (paper and electronic)
• Interface between clinical team, CRO and any other internal or external partners in the operational study conduct
• Preparation of contracts from templates for external Service Providers and consultants
• Control and follow up of study specific invoices
• Set up and maintenance of study tracking forms
• Compilation and distribution of study materials and documents
• Tracking of study data in Clinical Trial Management Systems (CTMS)
• Organization of meetings and taking minutes
• Support clinical study lead in tracking and following up on outstanding actions from the study team meetings
• Support audits and inspections by health authorities
• Min. 2 years of experience working in a clinical research environment, knowledge of the clinical trial process and GCP, experience in international clinical trials
• Excellent communication skills and proven team player in multidisciplinary, international settings
• Open minded, motivated personality with focus on details and good organizational skills
• Proficiency in all Microsoft office tools
• Fluent verbal and written English, German of advantage

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