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Clinical
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19000NVN Requisition #
Location:  This position will be located in Boston.
 

Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

In this exciting role as a Clinical Research Manager, you will have primary responsibility to manage 7 direct reports and 8-10 clinical studies across the MCS (Mechanical Circulatory Support) business focusing on the evidence portfolio, talent development, and functional/operational excellence. 

 

Come for a job, stay for a career.

 

Cardiac and Vascular Group (CVG)

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic, Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.

 

Within CVG, the Cardiac Rhythm and Heart Failure (CRHF) offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. 

 
A Day in the Life

The Clinical Research Manager will lead a small team supporting clinical studies in the MCS business focusing on the evidence portfolio, talent development, and functional/operational excellence.  This person will oversee study project plans, quality, execution, and financial management. Responsible for independently managing day-to-day activities including trial start-up, conduct, and closeout activities on (multiple) clinical trials of moderate to high complexity, or managing a broader range of activities on large multi-center studies and is expected to address and manage site, CRA and vendor related issues, with assistance as needed.  This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with MCS Business initiatives. This person must possess strong presentation, communication (oral and written), influence management, relationship (both internal and customer) and leadership skills.  This person will develop and motivate their team and adhere to training, quality, and compliance requirements.  This person will also help lead functional improvement projects across the clinical portfolio. 

 

Responsibilities may include the following and other duties may be assigned.

  • 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 aligned with the functional and business evidence strategy.
  • The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and completion of evidence efforts must be done in a timely matter and on budget with appropriate resources.
  • Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
  • Represents Medtronic from a clinical research perspective 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 focused on MCS studies across the CRHF portfolio.
  • May be assigned as a clinical member of a product core team
  • Provides direction to direct reports on general policies and management guidance, mentoring, objectives, and performance reviews
  • Maintain team development opportunities, engagement, and training compliance
  • Responsible for functional projects that add value to the clinical portfolio including trying new process improvements, system enhancements, and innovative resourcing.
  • Ability to navigate matrix organizations across geographies, functions, and business units
  • People management with 6-7 direct reports (local and remote Clinical Research Specialists). 

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 5 years of experience managing/leading clinical studies/trials, or advanced degree with a minimum of 3 years of experience managing/leading clinical studies/trials

Nice to Have (Preferred Qualifications):
  • Advanced Degree MS or PhD or MD.
  • 5+ years’ experience in device, biotechnical and/or pharmaceutical industry clinical trials.
  • People management experience / experience as a Clinical Research Manager with direct reports.
  • Cost-center/budget management experience.
  • Familiar with Medical Device and/or combination product trials and regulations.
  • Proficient knowledge of medical terminology.
  • Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials.
  • Significant knowledge of clinical and outcomes research study design.
  • Demonstrated ability to work effectively on cross-functional teams.
  • Oracle Electronic Data Capture experience.
  • Siebel Clinical Trial Management System experience.
  • Experience in conducting clinical trials in cardiovascular therapeutic indications.
  • Leadership skills include strong communication, problem solving, quality focus, business integration acumen, and change management. 
  • Experience in a high demand and fast-paced environment. 
  • Experience working with early technologies
  • Experience with innovative approaches to study design and execution
 

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)

 
Ability to travel up to 25%. 

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
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