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Job #02586

About our client Our client is a leading provider of innovative medical devices. An expert in designing, developing and manufacturing an expansive line of therapeutic and diagnostic devices, the company also markets its products. Their products aid in the management of non-coronary diseases, including peripheral vascular diseases. Position Location Manager of Clinical Affairs East Coast, USA Salary Reports to Highly competitive package, commensurate with experience Vice President – Regulatory Affairs/Quality Assurance Responsibilities 1) Establish clinical operational procedures and policies in compliance with GCPs 2) Train clinical sites in the use of products for clinical trials 3) Provide multi-center clinical trial monitoring, supplementary training and clinical support 4) Participate in the preparation of clinical protocols and reports 5) Ensure compliance with protocols, overall clinical objectives and FDA guidelines and regulations for devices through coordination of clinical sites staff, coordinators and investigators 6) Manage, maintain and audit clinical research files and records 7) Participate in managing the clinical database, ensuring its accuracy 8) Maintain system for tracking devices used in clinical trials 9) Manage the design, write-up and revision of SOPs, case record forms, site binders and other related monitoring and data evaluation information 10) Ensure that the conduct of clinical studies at the investigation sites are in compliance with the US and European GCPs 11) Manage and develop effective relationship with investigators 12) Train and assist investigators in completing study protocols 13) Evaluate new product concepts for potential new applications and clinical indication (may include evaluating the hazards associated with new and modified products as part of the Hazard Analysis Team) 14) Search literature for clinical background on new applications for the company’s technology 15) Prepare and track clinical budgets Requirements 1) BA/BS in Healthcare/Medical/scientific discipline (MA/MS preferred) 2) Minimum 5 years of increasing responsibilities in the execution and management of clinical trials in an FDA-regulated environment 3) Experience in oncology or cardiovascular preferred 4) Demonstrated competence and understanding of US and European GCPs and US regulatory requirements