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 Life
In 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:
OR
Nice to Have
Degree 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 Requirements
The 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 & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A 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 - $188,400.00
This 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 plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
About Medtronic
We 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 (http://www.medtronic.com) .
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.
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We 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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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