Senior Clinical Research Coordinator

Senior Clinical Program Manager (CPM)Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Plymouth, MN.In this exciting role as a Senior Clinical Program Manager (CPM), you will be responsible for leading the development and execution of the global clinical evidence strategy and roadmap for multiple medical device products in the Peripheral Vascular Health portfolio. You will define clinical evidence needs across released and pipeline products, identify evidence gaps, and implement fit-for-purpose strategies to generate data that supports regulatory, clinical, and business objectives. The CPM collaborates with internal and external stakeholders, builds partnerships with key opinion leaders to understand therapy and market needs, and maintains strong knowledge of product applications, relevant anatomy, and clinical use of Medtronic technologies.Role and ResponsibilitiesPlans and oversees clinical research programs from concept through completionDevelops and maintains detailed project plans, including timelines, budgets, resource allocations, decision logs, risks & mitigationsPrepares program dashboards to communicate the portfolio status, highlights, risks, mitigationsPresent to, and partner with, clinical and medical science team members and leadership on the overall health of the portfolio, successes, and areas of opportunityInteracts and works cross-functionally with (but not limited to) Clinical, Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, Market Development, R&D, and regions (US and OUS) to ensure program execution to achieve business goals within regulatory requirements.Ensure that clinical trials are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPsIdentifies and leverage innovative real-world data and real-world evidence opportunities to fulfill evidence requirements, optimizing time and costsIdentifies, builds and maintains meaningful partnerships with key opinion leaders and innovators to understand clinical therapy/market needs from a clinician's perspectiveCoordinates clinical evidence strategies with other cross-functions to ensure robust CRMS strategyServes as Core Team representative:Provides clinical subject matter expertise (SME) and CRMS representation on various technology development (pre-PDP), product development (PDP), continued development (CDP) and remediation projectsLeverages competitive intelligence around clinical/regulatory pathways, indications and labeling, claims, clinical evidence to inform and execute on differentiated and market leading evidence that support business stakeholdersDetermines burden of evidence for our products and partners with core team stakeholders to develop innovative clinical development plans to ensure timely product launch in target regions and market access and adoptionInvolved in changes to systems/products and what may be required to support this from a clinical perspectiveKeeps current on over-arching core team project priorities and deliverablesClinical Study Support and Oversight:Provides input into clinical investigation documents to ensure alignment with overall business strategy, including: Protocols, Case Report Forms, Informed Consent Forms, Clinical Study Reports etc.May lead document development and execution of studiesInterprets and ensures dissemination of results of clinical investigations in preparation for new device or supporting applicationWorks with statistical team on analysis of data from MDT-internal and external databases, as appropriateLeads cross-functional project teamsFacilitates communication and collaboration among team members, stakeholders, and external partnersProvide regular updates to senior management and cross-functional leaders on project status, risks, and issuesRegulatory Compliance and Engagement:Ensures that all clinical research activities comply with applicable regulatory requirements and ethical standardsMay prepare and submit regulatory documents, including protocols, informed consent forms, and progress reportsMay coordinate with regulatory authorities and ethics committees to obtain necessary approvalsProvides input and review, as appropriate, clinical evaluation documents to ensure alignment with overall product MDR strategy, including: Clinical Evidence Plan (CEP), PMCF plan, PMCF report, Clinical Evaluation Report (CER)Risk management file and IFU developmentSupports global regulatory submissionsData and Results Interpretation:Oversees data collection, management, and analysis to ensure accuracy and integrityWorks with data management and biostatistics teams to develop data management plans and statistical analysis plansEnsures timely and accurate reporting of study resultsDrives the global publication and evidence dissemination strategy through close collaborations with Medical Science, healthcare economics, global portfolio and marketing functionsBudget Management:Performs financial budget modeling and scenario planning around evidence needsAdvocates for appropriate support and funding for highest priority projects, in conjunction with cross-functional evidence teamDevelops and manages program budgets, including forecasting and tracking expensesEnsures that projects are completed within budget and on scheduleIdentifies and mitigates financial risksAdditional Responsibilities:Builds and maintains a strong network and close relationship with the various internal and external parties.Maintains strong understanding of product knowledge, relevant anatomy, and accepted applications and uses associated with our productsUtilizes subject matter expertise to provide clinical input to various functions (General Management, Global Strategy & Portfolio Management, Business Development & Licensing, Research & Development, & Marketing) and organizational units to facilitate insightful decision-making and enable achievement of business objectives.Critically evaluates due diligence information for inorganic opportunitiesUnderstands that needs and funding will change over timeEffective leadership and team facilitation skills to motivate cross-functional and cross-business unit partners to work towards common clinical evidence goalsAssesses project issues and develops resolutionsDevelops mechanisms for monitoring project progress and for intervention and problem solvingUnderstands the market and competitive spaceProvides marketing material review for clinical evidence claims as neededProvides scientific input for evidence generation including sponsored research, ERPs, Scientific Services, Collaborative Research and Alternative Data Source projectsMust Have (Minimum Requirements):Bachelor's degree with minimum 7 years of experience in clinical research/clinical strategy in the healthcare industryOr an advanced degree with minimum 5 years of experience in clinical research/clinical strategy in the healthcare industryNice To HaveDegree in engineering, life sciences, or related medical/scientific fieldClinical research/clinical trials experience at Medtronic or within a medical device industryExperience in clinical operationsExperience developing clinical strategies and study designExperience in Peripheral or Endovenous therapies/productExperience working on a global study teamBasic understanding of biostatistics and trial designExperience in Research and Development (R&D)Project/program management skills/experienceAbility to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as neededProficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applicationsPMP certification; Project Management Certification (preferably PMI) and/or