At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 CRM will report to the US Sr. Clinical Research Director 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.

• Bachelors 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) degree defined as engineering life sciences or related medical/scientific field.
• Leadership skills include strong communication problem solving quality focus business integration acumen and change management.
• Demonstrated ability to work effectively globally on cross-functional teams.
• Clinical Research experience at Medtronic or within a medical device industry preferably in cardiovascular area
• Experiencemanaging direct reports and leading clinical -center/budget management experience.
• Experience in medical device clinical product trials and regulations.
• Expertise withGood Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials
• Experience in clinical trial design as well as 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
• Experience in a high-demand and fast-paced environment.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.