Senior Clinical Research Progran Manaager

Medtronic • Plymouth, MN

4d • $166,400 - $249,600 • Onsite

About The Position

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. 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
• 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

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
• 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
• 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
• 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
• 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
• 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
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior