Senior CTM, Non-Interventional/Observational Studies

10 ago - Italia
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as a Senior Clinical Team Manager - Make an Impact at the Forefront of Innovation

The Senior Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. The role involves working to ensure that all clinical deliverables meet the customer's time/quality/cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically the Senior Clinical Trial Manager works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.





We are looking for experienced Sr CTMs with previous experience in the role and preferably experience in the Start Up Team Manager role. Previous experience in non-interventional / Phase IV studies is also preferable

What You'll Do:
• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participa

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