Clinical Research Program Manager - Acute Care and Monitoring at Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeIn this exciting role as a Clinical Research Program Manager, you will have primary focus responsibility to develop global clinical evidence generation strategies across products in alignment with Medtronic market launch and market development business needs. You will engage and manage relationships with R&D, Medical Affairs, Marketing, Market Development, global business partners, and other internal and external cross-functional partners to satisfy program needs. Location: Boulder, Colorado or Minneapolis, MN (preferred), open for remote location within the U.S.. Travel up to 25% (primarily domestic and occasionally international). The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.Responsibilities may include the following and other duties may be assigned.Program Management: Leads development and implementation of overall global clinical evidence strategy and roadmap for multiple medical device product(s) and/or remote monitoring system(s): Defining clinical evidence needs for current (released product) and new product portfolios Collaborates with key internal and external global stakeholders to identify evidence gaps Executes a fit-for-purpose strategy to acquire the necessary data to support the desired objectives, including identifying the level of clinical evidence required to satisfy identified business objectives Identifies and leverage innovative real-world data and real-world evidence opportunities to fulfill evidence requirements, optimizing time and costs Leverages latest literature, regulations and guidance to build and execute on evidence strategies Identifies, builds and maintains meaningful partnerships with key scientific influencers and innovators to understand clinical therapy/market needs from a clinician’s perspective Coordinates clinical evidence strategies with other cross-functions to ensure robust CRMS strategy Serves 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 projects Leverages 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 stakeholders  Determines 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 adoption Involved in changes to systems/products and what may be required to support this from a clinical perspective Keeps current on over-arching core team project priorities and deliverables Plans and oversees clinical research programs from concept through completion Develops and maintains detailed project plans, including timelines, budgets, resource allocations, decision logs, risks & mitigations Prepares program dashboards to communicate the portfolio status, highlights, risks, mitigations  Present to, and partner with, clinical and medical affairs team members and leadership on the overall health of the portfolio, successes, and areas of opportunity Interacts 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 SOPs Clinical 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 studies Interprets and ensures dissemination of results of clinical investigations in preparation for new device or supporting application Works with statistical team on analysis of data from MDT-internal and external databases, as appropriate Leads cross-functional project teams Facilitates communication and collaboration among team members, stakeholders, and external partners Provide regular updates to senior management and cross-functional leaders on project status, risks, and issues Regulatory Compliance and Engagement: Ensures that all clinical research activities comply with applicable regulatory requirements and ethical standards May prepare and submit regulatory documents, including protocols, informed consent forms, and progress reports May coordinate with regulatory authorities and ethics committees to obtain necessary approvals Provides 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 development Supports global regulatory submissions  Data and Results Interpretation: Oversees data collection, management, and analysis to ensure accuracy and integrity Works with data management and biostatistics teams to develop data management plans and statistical analysis plans Ensures timely and accurate reporting of study results Drives the global publication and evidence dissemination strategy through close collaborations with Medical Science, healthcare economics, global portfolio and marketing functions Budget Management: Performs financial budget modeling and scenario planning around evidence needs Advocates for appropriate support and funding for highest priority projects, in conjunction with cross-functional evidence team  Develops and manages program budgets, including forecasting and tracking expenses Ensures that projects are completed within budget and on schedule Identifies and mitigates financial risks Quality Assurance: Maintains quality assurance processes to ensure the integrity and reliability of clinical research data Contributes to regular audits and inspections to ensure compliance with GCP and company SOPs Addresses and resolves any quality issues that arise during the course of the program Training and Development: Provides training and mentorship to clinical research staff Stays current with industry trends, regulatory changes, and best practices in clinical research and therapy area Promotes a culture of continuous improvement and professional development  ​Additional 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 products Utilizes 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 opportunities Understands that needs and funding will change over time Effective leadership and team facilitation skills to motivate cross-functional and cross-business unit partners to work towards common clinical evidence goals Assesses project issues and develops resolutions Develops mechanisms for monitoring project progress and for intervention and problem solving Understands the market and competitive space Provides marketing material review for clinical evidence claims as needed Post-market Clinical surveillance reviews Helps with responses to unsolicited requests for information from business or regional partners, as appropriate Assesses investigator-initiated research proposals and manages clinical collaborative research programs Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval. Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines. The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter. Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies. Ensures regulatory submissions are accurately prepared and comply with regulatory approvals. People working within region/country may also have the responsibilities that include: Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities. Builds and maintains a strong network and close relationship with the various internal and external parties. Required Knowledge and Experience: Bachelor's degree with 5+ years of experience in clinical research/clinical strategy in the healthcare industryORAn advanced degree with 3+ years of experience in clinical research/clinical strategy in the healthcare industryNice to HaveDegree in Engineering, life sciences, or related medical/scientific field.  Clinical Research experience at Medtronic or within a medical device industry. Experience working on a Global study team Experience in managing clinical trial data review and multiple clinical research sites with proven results in study execution Comprehension and understanding of Clinical affairs functional systems and processes Demonstrated clinical acumen across the care continuum and working with clinicians Working knowledge of FDA and key International regulations, standards and guidances Basic understanding of biostatistics and trial design Excellent project management and organizational skills. Thrives in a dynamic environment and flexibility to adapt to changing priorities Proficient experience using Microsoft Word, Power Point, and Excel  Competencies: Self-directed demonstrating high degree of initiative Integrity and trust, drive for results, building effective teams, action-oriented Solid understanding of the industry  Determining, understanding and being able to communicate the “unmet clinical needs”  Strong strategic thinker Critical thinking Ability to motivate and drive accountability among cross-functional team members Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills. Ability to communicate complex information in a clear, concise manner Experience working in cross-functional teams in a highly matrixed organization Proven ability to cultivate an active network of relationships within and outside of the organization Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Salary ranges for U.S (excl. PR) locations (USD):$125,600.00 - $188,400.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).Medtronic benefits and compensation plansAbout MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity here.It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.At Medtronic, most positions are posted on our career site for 3-7 days.  SummaryLocation: Boulder, Colorado, United States of America; Minneapolis, Minnesota, United States of AmericaType: Full time