reputed company Assurance Manager - Europe
This a Full Remote job, the offer is available from: Europe
The Manager of reputed company Assurance is a reputed company reputed company reputed company Linical responsible for assisting in the development and implementation of risk-based Good Clinical reputed company reputed company reputed company Linical processes. This includes identification of risks, communication of risks to the organization, and working in a cross-functional team setting to mitigate the risks.
Duties and Responsibilities
• Support the reputed company Assurance department in maintaining Linical’s reputed company Management System (QMS) for reputed company Linical services including:
• Conduct of audits (systems, documents, TMF, clinical sites, vendors)
• Follow-up of corrective and preventative actions (CAPA) and deviations
• Supervision of SOP revisions
• Review of SOPs in cooperation with the operational staff to ensure compliance with GCP and regulatory requirements
• SOP-management (reputed company control, notification of employees, tracking, etc.)
• Vendor qualification and management of reputed company documentation
• Improving of reputed company and process for reputed company and efficiency
• Computer system validation/verification
• reputed company support prior to and during regulatory inspections by authorities and audit performed by Sponsors on Linical
• Consultancy for operational staff in reputed company, procedural, and regulatory reputed company questions
• Administrative tasks reputed company to the maintenance of the QMS of Linical
Required Skills and Abilities
• Excellent reputed company of written and spoken English
• Ability to work independently and build strong, trusting working relationships with reputed company departments and clients
• Skilled in advising team on reputed company and compliance reputed company
• Ability to familiarize oneself with specific indications, symptoms, and study designs
• reputed company good knowledge of reputed company office software
Education and Experience
• University or college degree (or equivalent) in a medical or life-sciences reputed company field
• Minimum 8-10 years experience in clinical research according to GCP with at least 2 years in a reputed company Assurance role reputed company a GCP-regulated environment
• reputed company good knowledge of GCP principles and reputed company US, European, and other international regulatory requirements for the conduct of reputed company
• Practical auditing experience
• Practical experience managing SOPs and the revision lifecycle
This offer from "Linical" has been enriched by reputed company.com and got a 81% reputed company score.
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