Manager, Clinical Affairs

Job Summary –Primary responsibilities for this position include Outcomes (non-IDE) study management and data reporting for clinical trials on devices that have been cleared by the FDA. The manager is responsible for study development and providing direction to, and assistance for, Clinical Research Associates (CRA) managing clinical trials. This position will provide the leadership and direction for multiple, simultaneous outcomes registries and studies designed to support the commercialization for new products cleared by the FDA. Routine interaction with research management to provide comprehensive enrollment documentation, institution ethics committee approval status, and the development of publications from the Registry programs is required. General Functions –· Leads the Research and protocol development for new technology in the fields of Trauma, Shoulder, Hip and Knee.· Manages all study related issues for Zimmer clinical outcomes studies and prospective randomized, non-IDE clinical studies.· Individual must be comfortable multitasking and managing many simultaneous requests for field support for studies.· Demonstrated ability to impact and influence others within a team to take action; interacts effectively with various functional groups of the project team; contributes significantly towards the establishment of best practices; serves as a resource and mentor.· Demonstrates problem-solving strategies developing alternative solutions and contingencies to address issues as they occur.· Supports coaching and feedback and as appropriate, provides performance input to senior management.· Manages the process to develop peer-reviewed manuscripts on data received in Zimmer sponsored studies. · Serves as a grant manager for select sites in conjunction with the External Research Process. Prepares and routes externally funded research protocols and grant applications in compliance with Zimmer policies.· Independently identifies potential barriers to project completion and proactively implement effective strategies to avoid such barriers.· Demonstrates ability to effectively communicate to all levels of the organization.· Effectively oversees, supervises, directs, delegates, assists, and advises Clinical Research Associates/Specialists monitoring clinical outcomes studies. · Demonstrated 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, assist in the development of the clinical plan.· In conjunction with the senior members of the project team (product management, research, engineering and regulatory affairs) manages administrative aspects of a clinical project/study including, training, study initiation, trial maintenance, data monitoring, data reporting, and payments.· Supervises and coordinates clinical monitors workload within a project, as required; Plans and initiates the steps involved in the clinical research process; in conjunction with the clinical project leader, manages all aspects of a project in accordance with established timelines, applicable project standards and standard operating procedures.· Monitors the progress of the project and updates clinical project leader on an ongoing basis; assists in the resolution of identified issues and assists in the resolution of more complex issues presented by the clinical scientist and engages director as needed.· Prepares, oversees, and reviews the preparation of clinical documents, e.g., 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.· Assures GCP compliant documentation system that maintains patient confidentiality.This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADAExpected Areas of Competence (i.e. KSAs) –§ Demonstrated 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, assist in the development of the clinical plan.§ Supervises and coordinates clinical monitors workload within a project, as required; Plans and initiates the steps involved in the clinical research process; in conjunction with the clinical project leader, manages all aspects of a project in accordance with established timelines, applicable project standards and standard operating procedures.Education Requirements – Requires a Bachelor’s degree in health, life sciences, or engineering. Minimum of three years experience with IDE or outcomes studies in medical devices with direct responsibility for submissions development and content. Masters degree preferred.Skill Requirements – Previous direct clinical study design, FDA interaction and negotiation, and study launch experience. Minimum three years successful experience in an orthopaedic clinical management role. Two years experience in supervising and directing three to five CRA’s. Previous demonstrated experience in, and responsibility for study budget, enrollment, inventory and progress reporting.Travel Requirements – 30%Education: BachelorsJob Level: 6 - 7 yearsPercent Travel: 21-30%