We anticipate the application window for this opening will close on - 31 Mar 2025

 

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 the Senior Clinical Research Manager (Sr. CRM) in the Surgical Operating Unit, you will have primary responsibility for overseeing the management, execution, and daily activities of the clinical studies in Robotic Surgical Technologies (RST) Business Unit. This managerial role reports to the Sr Director of Clinical Research for RST/DT. The Sr CRM will independently handle various clinical study assignments, have management responsibility, help support the overall clinical strategy for the business and oversee and direct the work of a team of Clinical Research Specialists.

Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes. Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.
We're making that exciting future possible — and disrupting one of the biggest and fastest growing markets in healthcare — with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions.

Location: Remote from the U.S.

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.
• 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.
• Collaborates and implements clinical/regulatory strategies to obtain timely product approvals from worldwide regulatory bodies.
• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
• May be assigned to support new product development representing the clinical function on the Core Team
• 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.
• 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.
• 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.
• Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives). 
• Leads talent development, hiring, coaching
• Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs.  Provide management level representation during audits.
• Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, and Regulatory Affairs) to drive clinical wide or cross-departmental initiatives
• Oversees 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.   
• 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 and minimum of 7 years of clinical research experience with 5+ years of managerial experience

OR

• An advanced degree with a minimum of 5 years of clinical research experience with 5+ years of managerial experience

Nice to Have:

• Adva