Clinical Trial Manager, Peripheral Interventions
About the position The Clinical Trial Manager is responsible for executing Peripheral Interventions Global Clinical Strategy through the design, planning, execution, and leadership of clinical evidence generation and programs worldwide. In this role, you are responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. This role interfaces with Senior Clinical Management, Medical Director, Divisional Management as well as with physicians and external contacts. This is a hybrid position (in the office minimum for three days per week) to be located in Maple Grove, Minnesota. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. Responsibilities • Independently drives and/or leads project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical evidence generation. • Leads, directs and executes clinical trials and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. • Tracks development of, and collaborates with the project team on, all internal and external project materials, processes, manuals, plans, committees, clinical systems and sponsor required regulatory submissions. • Develops clinical study protocols and reviews/approves supporting documentation. • Ensures the project team maintains a continuous state of audit readiness. • Leads the proactive identification, assessment, and management of clinical evidence generation risks. • Informs and presents evidence generation progress and known risks to Senior Leadership. • Authoring clinical study reports in collaboration with cross-functional teams. • May train, develop, mentor, and supervise clinical staff. • Develops and maintains strong relationships with clinical study sites and KOLs. • Provides clinical input to product development activities; represents Clinical on product development teams. Requirements • Minimum Bachelor's degree in healthcare. • Minimum 7 years of related work experience or an equivalent combination of education and work experience. • Minimum 3 years of experience managing clinical trials. • Proven Project management experience including financial acumen: managing scope, budget and timelines. • Previous or current leadership, indirect or direct people leadership required. • Proven ability to manage multiple complex projects and lead in a matrix organization. • Established knowledge of Good Clinical Practices (GCP) and FDA regulations governing the conduct of clinical trials. • Ability to travel up to 20%, as needed. Nice-to-haves • Proven experience with product approval maintenance activities such as PMCF evidence generation, literature searches, contribution to CER's, etc. • Ability to work collaboratively and influence a broad range of global stakeholders. • Ability to maintain strategic perspective and align activities with business vision and purpose. • Ability to respond flexibly and positively under conditions of uncertainty or change. • Ability to independently implement action plans and align activities with project, program and business objectives without significant supervision. Benefits • 401k • health_insurance • dental_insurance • vision_insurance • life_insurance • disability_insurance • paid_holidays • paid_volunteer_time • tuition_reimbursement • professional_development • employee_stock_purchase_plan Apply tot his job Apply tot his job