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Clinical Research Manager-
MedtronicUSA-MN, United Statesfull_timeVerifiedPosted 7 Nov 2024
💰 $188,400/yr
About the role
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
CLINICAL RESEARCH MANAGER – Surgical Robotics Operating UnitIn this exciting role as the Clinical Research Manager (CRM) in the Surgical Robotics Operating Unit, 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. You will also be responsible for creating and executing business strategy and influencing internal and external customers to drive business results. This is a managerial role. The CRM will report to the Clinical Research Director and independently handle various clinical programs and clinical study assignments, have management responsibility, and oversees and directs the work of a team of Sr Clinical Research Specialists, Clinical Research Specialists, and/or Project Coordinators as required.
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
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.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
• Develops and implements clinical evidence strategies to obtain timely product approvals from worldwide regulatory bodies.
• May be assigned to support new product development representing the clinical function on the Core Team
• 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.
• 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.
• 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).
• 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.
Responsibilities may include the following and other duties may be assigned.
- Provides leadership for the conduct of clinical st
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