22 days old

Senior Manager, Clinical Research - Cardiac Ablation Solutions

Medtronic
Minneapolis, MN 55415
  • Job Code
    210002E2

Careers That Change Lives

In this exciting role as a Senior Clinical Research Manager (Sr CRM), you will have primary responsibility to oversee the management, execution and daily activities of the Medtronic sponsored, Cardiac Ablation Solutions (CAS) Clinical portfolio as well as to develop and implement strategies to enhance the capabilities and performance of the organization. The Sr CRM will independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Specialists, Field Clinical Engineers (AFX), and/or Project Coordinators as required.

This role reports to the leader of Medtronic Cardiac Ablation Solutions Clinical organization and will sit on the CAS Clinical Leadership team.

The Cardiac Ablation Solutions (CAS) business is one of the fastest growing businesses and helps patients all over the globe requiring mapping and ablation for cardiac arrhythmias.

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. We want employees who think critically about healthcare problems and/or opportunities to advance science faster than others.

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.

To learn more about Inclusion & Diversity at Medtronic Click Here

This is a remote based role so the candidate can live anywhere in the U.S.

Travel up to 15%, domestic/international

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- and 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.
  • Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
  • 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 CAS therapies.
  • 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 a minimum of 7 years of experience in clinical research/medical affairs with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in clinical research/medical affairs with 5+ years of managerial experience

Nice to Have (Preferred Qualifications):
  • Advanced degree (Masters, PhD or MD) preferred. Technical degree defined as engineering, life sciences or related medical/scientific field
  • Experience managing direct reports and leading clinical teams, including field-based teams
  • 7+ years' experience managing multiple clinical research studies at Medtronic or in medical device industry
  • Experience managing cardiovascular medical device and/or pharmaceutical trials
  • 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 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

Competencies:
  • Leadership skills include strong communication, accountability, 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)

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.

Learn more about our benefits at benefits.medtronic.com

Additional Information

  • Posting Date: Feb 8, 2021
  • Travel: Yes, < 25 % of the Time






Posted: 2021-02-09 Expires: 2021-03-10
Sponsored by:
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Sponsored by:
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Senior Manager, Clinical Research - Cardiac Ablation Solutions

Medtronic
Minneapolis, MN 55415

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