The Clinical Trial Specialist is responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). The CTS will be assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be dependent on department workload and need). The person will be responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, and quality standards.
Clinical Trial Specialist
Global Pharma Company
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BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background
As per Industry
The candidate should have relevant experience in clinical trial management (e.g. study management in a multi- national environment using different models for trial execution). The candidate should be able to train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility. He/She should be able to author the clinical study protocol and other study essential documents.
Englisch: Sehr gut
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