Senior Clinical Research Progran Manaager

Medtronic•Plymouth, MN

3d•$166,400 - $249,600•Onsite

About The Position

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life 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.

Requirements

Bachelor's degree with minimum 7 years of experience in clinical research/clinical strategy in the healthcare industry
Or an advanced degree with minimum 5 years of experience in clinical research/clinical strategy in the healthcare industry

Nice To Haves

Degree in engineering, life sciences, or related medical/scientific field
Clinical research/clinical trials experience at Medtronic or within a medical device industry
Experience in clinical operations
Experience developing clinical strategies and study design
Experience in Peripheral or Endovenous therapies/product
Experience working on a global study team
Basic understanding of biostatistics and trial design
Experience in Research and Development (R&D)
Project/program management skills/experience
Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification
Thrives in a dynamic environment and flexibility to adapt to changing priorities
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

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 science 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
Identifies and leverage innovative real-world data and real-world evidence opportunities to fulfill evidence requirements, optimizing time and costs
Identifies, builds and maintains meaningful partnerships with key opinion leaders 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
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
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
Provides scientific input for evidence generation including sponsored research, ERPs, Scientific Services, Collaborative Research and Alternative Data Source projects

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)