Clinical Trials Research Manager: Medical Devices

Clinical Research Manager: Medical Equipment/Devices Midwest: NE Indiana Our client a Midwest based medical device company seeks an experienced clinical research manager for their Outcomes study management and data reporting for clinical trials on devices already FDA cleared. As manager, you will provide leadership for multiple outcomes registries/studies designed to support the commercialization for new products. Your responsibilities will include:§  Study development and providing direction to, and assistance for, Clinical Research Associates (CRA) managing clinical trials. §  Regular interface with research management to provide comprehensive enrollment documentation, ethics committee approval status, and the development of publications from the Registry programs is required. §  Guide the research and protocol development for new technology §  Manage and multitasking all study related issues for clinical outcomes studies and prospective randomized, non-IDE clinical studies.§  Direct the process to develop peer-reviewed manuscripts on study data§  Prepare and route externally funded research protocols and grant applications §  Supervise Clinical Research Associates/Specialists monitoring clinical studies §  Collaborate with the senior members of the project team§  Organize administrative aspects of a clinical project/study including, training, study initiation, trial maintenance, data monitoring, data reporting, and payments §  Organize and review clinical documents including Protocols, Investigator Brochure, Annual Report updates, Case Report Forms and Clinical Study Reports; participates in the preparation of integrated documents for all clinical outcomes studies. Requirements:R  BS in health, life sciences, or engineering, MS a plusR  4+ years of clinical trial related experience including:R  2+ years clinical experience in orthopedics or related medical devicesR  2+ years directing clinical study design, study budget responsibilities, enrollment, inventory, and progress reporting.R  2+FDA interaction and negotiation, and study launch experience. R  2+ years experience in managing CRA's. R  2+ years experience with IDE or outcomes R  Ability to Travel up to 30% Relocation assistance available to NE IndianaInterested?  Submit your resume to Dave Schmitt at David@mriweston.com or call Dave at 954-385-3122 MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: NE Indiana, IN JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: Clinical Trials Manager COMPANY: MRINetwork CONTACT NAME: David Schmitt PHONE: 954-385-3122 EMAIL: Apply by Email