We anticipate the application window for this opening will close on - 6 Jun 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

Location: Remote position within the United States
Travel: up to 25% (domestic and may include international travel).

In this exciting role as a Clinical Research Manager (CRM), you will have primary focus responsibility to oversee all clinical activities related to one or more clinical studies and performing/directing/managing the daily in-house activities associated with the studies. This is a people leadership role. The CRM will report to the US Sr. Clinical Research Manager and independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Specialists at all levels, from entry level to tenured.

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.
• 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.

Other responsibilities:

• Accountable for 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 in consultation with the cross-functional project team, investigators, data management, and biostatistics.
• Provides management review 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.
• Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives, employee training).  
• Collaborate with the Field Clinical Organization   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, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives
• May oversee activities performed by Contract Research Organizations (e.g., CROs, core labs).
• 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.
• Minimum of 5 years of Clinical Research experience
• Or an advanced degree with 3 years of Clinical Research experience

Nice to Have (Preferred Qualifications):

• Advanced degree (Masters, PhD or MD) preferre