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Senior Manager, Clinical Research - Structural Heart

Company: Medtronic GmbH
Location: Costa Mesa
Posted on: February 25, 2021

Job Description:

Senior Manager, Clinical Research - Structural Heart In this exciting role as a Senior Manager, Clinical Research (Sr CRM), you will have primary focus responsibility to oversee all clinical activities related to one or more clinical studies and performing/managing the daily in-house activities associated with the studies. This is a managerial role. The Sr CRM will report to the Clinical Research Director and independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Managers, Principal Clinical Research Associates, Sr Clinical Research Associates, Clinical Research Assistants, and/or Project Coordinators as required. The Structural Heart Business is one of the fastest growing businesses and helps patients all over the globe needing valve replacement.--
We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. This role reports to the leader of Medtronic Clinical Programs for Mitral and Tricuspid Therapies. This role is responsible for providing daily oversight/management of operations and execution of deliverables as well as to develop and implement strategies to enhance the capabilities and performance of the organization. You'll always have new challenges pursuing ideas that are exciting, innovative, and just plain cool. Build out the future of robotic healthcare. Think critically about healthcare problems and/or opportunities to advance science faster than others. Do research on improving the healthcare of millions.-- We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Primary location is Mounds View, MN; would consider remote. Travel up to 25% (domestic and may include international travel). A Day in the Life Responsibilities may include the following and other duties may be assigned.

  • Provides leadership for the conduct of clinical studies and in the development of clinical evidence for pre an post-market trials/studies as it applies to product lifecycle.
  • 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.
  • Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.
  • Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections of the Investigational Device Exemption (IDE) in consultation with the cross-functional project team, investigators, data management, and biostatistics.
  • Provides management review and approval of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities.
  • Oversee accuracy of clinical studies/projects.
  • Develop and manage cost center budget and study budgets.
  • Ensures appropriate resources and priorities are maintained for the various projects assigned to their area. Oversees Clinical Research staff with all aspects of their responsibilities. May interface with regulatory agencies, as appropriate.
  • Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs. Compile, review, and conclude device complaints. Provide management level representation during audits.
  • Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives). Assist data management group with review of clinical data/information and provide oversight of data correction.
  • Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives.
  • Work with Clinical Customer Service to control device allocation, distribution, and reconciliation. Manages activities performed by Contract Research Organizations (e.g. CROs, core labs).
  • Oversees the clinical department SOP/DOP review and development, employee training, and associated requirements. Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of Pre-Market Approval (PMA) submissions.
  • May organize and direct investigator conferences to review findings and advise on study direction, as needed.
  • Provide input and support for post-clinical activities and market launch of products. May co-author results of studies for medical literature and/or presentations at scientific meetings. Must Have (Minimum Requirements): To be considered for this role, the minimum requirements must be evident on your resume.
    • Bachelor's degree required and minimum of--7--years of clinical research experience with 5+ years of managerial experience, or advanced degree and minimum of--5--years of clinical research experience with--5+ years of managerial experience * Managerial/leadership experience (i.e., experience as a manager having direct or indirect reports, people leader) Nice to Have (Preferred Qualifications):
      • Advanced degree (Masters, PhD or MD) preferred. Technical degree defined as engineering, life sciences or related medical/scientific field.
      • 7+ years' experience managing multiple clinical research studies--at Medtronic--or in medical device industry
      • Experience managing cardiovascular medical device
      • Experience--managing direct reports and leading clinical teams. Cost-center/budget management experience.
      • Experience in medical device clinical product trials and regulations.
      • Expertise with--Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials
      • Experience in clinical trial design, as well as managing clinical trials from start to finish.
      • Global clinical trial strategy and execution, and outcomes research study design.
      • Product development experience including global clinical strategy development
      • Leadership skills include strong communication, problem solving, quality focus, business integration acumen, and change management.--
      • Demonstrated ability to work effectively globally on cross-functional teams.
      • Experience in a high-demand and fast-paced environment.-- About Medtronic

        Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.--

        We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.--

        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. (ADA-United States of America). Travel up to 25%. Check out benefits.medtronic.com 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. This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 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. 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 .

Keywords: Medtronic GmbH, Costa Mesa , Senior Manager, Clinical Research - Structural Heart, Healthcare , Costa Mesa, California

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