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Job #03127

About our client Our client is a worldwide leader in orthopedics and has been very innovative since its founding more than 75 years ago. Their hip and knee joint replacement systems and wide range of related products and services make our client valuable partners to health care providers in 100 countries. This is an exciting opportunity for the right person to join a stimulating work environment focused on being the best – designing and building the best possible systems and delivering the best package of value-added services for their customers Position Location Clinical Affairs Manager Warsaw, Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle study management and data reporting for clinical trials on devices that have been cleared by the FDA 2) Provide leadership and direction for multiple, simultaneous outcome registries and studies designed to support the commercialization for new products cleared by the FDA 3) Handle study development as well as provide direction to and assistance for CRAs managing clinical trials 4) Interact with Research management to provide comprehensive enrollment documentation, institution ethics committee approval status and the development of publications from the registry programs 5) Lead the research and protocol development for new technology in trauma, shoulder, hip and knee areas 6) Manage all study-related issues for clinical outcomes studies and prospective randomized, non-IDE clinical studies 7) Multitask and manage many simultaneous requests for field support for studies 8) Demonstrate ability to impact and influence others within a team to take action 9) Interact effectively with various functional groups of the Project Team 10) Contribute significantly towards the establishment of best practices 11) Serve as a resource and mentor 12) Demonstrate problem-solving strategies as well as develop alternative solutions and contingencies to address issues as they occur 13) Support coaching and feedback (as appropriate) 14) Provide performance input to senior management 15) Manage the process to develop peer-reviewed manuscripts on data received in company-sponsored studies 16) Serve as a Grant Manager for select sites in conjunction with the external research process 17) Prepare and route externally funded research protocols and grant applications in compliance with company policies 18) Identify potential barriers to project completion and proactively implement effective strategies to avoid such barriers 19) Demonstrate ability to effectively communicate with all levels of the organization 20) Oversee, supervise, direct, delegate, assist and advise CRAs and Specialists, monitoring clinical outcomes studies 21) Demonstrate expertise and strong understanding of the overall project goals, the indication(s) studied and the purpose of the planned studies in meeting the objectives of the project 22) Assist in the development of the clinical plan 23) Manage administrative aspects of a clinical project/study (training, study initiation, trial maintenance, data monitoring, data reporting and payments) 24) Supervise and coordinate Clinical Monitor’s workload within a project (as required) 25) Plan and initiate the steps involved in the clinical research process with the Clinical Project Leader 26) Manage all aspects of a project as per established timelines, applicable project standards and standard operating procedures 27) Monitor the progress of the project and update Clinical Project Leader on an ongoing basis 28) Assist in the resolution of identified issues and assist in the resolution of more complex issues presented by the Clinical Scientist and engage the Director 29) Prepare, oversee and review the preparation of clinical documents (e.g. protocols, investigator brochure, annual report updates, CRFs and clinical study reports) 30) Participate in the preparation of integrated documents for all clinical outcomes studies 31) Ensure GCP compliant documentation system that maintains patient confidentiality Requirements 1) Bachelor’s degree in Healthcare, Life Sciences or Engineering (Master’s degree preferred) 2) Minimum 3 years of experience in IDE or outcomes studies in medical devices with direct tasks for submissions development and content 3) Minimum 3 years of successful experience in an orthopedic clinical management role 4) Minimum 2 years of experience in supervising and directing 3 – 5 CRAs 5) Previous experience in direct clinical study designing 6) Experience in FDA interaction, negotiation and study launch 7) Demonstrated experience in study budget, enrollment, inventory and progress reporting 8) Willingness to travel (up to 30%)