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
The Senior CRS is responsible for clinical study management, primarily focusing on clinical site management for an ongoing, exciting, and innovative clinical study. The CRS is responsible for developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and alignment with Medtronic's business needs.
Responsibilities may include the following and other duties may be assigned:
- Oversees the conduct of clinical evaluation research studies with a primary focus on clinical site management.
- Support preparation of protocols and patient record forms.
- Conducts registered and non-registered clinical studies of products satisfying a medical need and offering commercial potential.
- Oversees and interprets results of clinical investigations in preparation for new drug devices or consumer applications.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and under standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations, and may prepare clinical trial budgets.
- May be responsible for clinical supply operations and site and vendor selection.
- People working within a region/country may also have responsibilities that include:
- Represents Medtronic from clinical research within the country/region and collects feedback from local customers and authorities.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
Required Knowledge and Experience:
Requires a Baccalaureate degree in engineering, life sciences, or related medical/scientific field.
Minimum of 4 years of clinical research experience or advanced degree with a minimum of 2 years experience.
Nice to Have
- 5+ years’ experience managing clinical trials within Medtronic or medical device industry.
- Experience managing multiple clinical research sites with proven results in study execution.
- Experience in managing clinical trial data review.
- Basic understanding of biostatistics and trial design.
- Experience in Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020.
- Experience in Pain management therapies/products.
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.
Salary ranges for U.S (excl. PR) locations (USD): $105,600.00 - $158,400.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
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 90,000+ 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.
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
At Medtronic, most positions are posted on our career site for 3-7 days.