Medtronic Sr Clinical Research Specialist North Haven , Connecticut Apply Now
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 a Senior Clinical Research Specialist (Sr. CRS) in our Surgical Operating Unit, you will have primary responsibility in the execution and oversight of global clinical studies. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. Most of the time is spent delivering and overseeing the projects – from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Assumes project management responsibilities for selected studies and site management activities as needed.
Responsibilities may include the following and other duties may be assigned:
- Oversees, designs, plans and develops clinical research studies.
- Prepares and authors protocols and patient record forms.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with 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, site, and vendor selection.
- Represents Medtronic from a clinical research perspective within the country / region and also collects feedback from local customers and authorities. Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Drives local evidence dissemination & awareness.
- Additional tasks as assigned.
Must Have: Minimum Requirements
- Bachelor’s Degree with 4 years of clinical research experience
- OR
- An advanced degree with 2 years of clinical research experience
Nice to Have
- Degree in engineering, life sciences, or related medical/scientific field
- 5+ years’ experience managing clinical trials within Medtronic or medical device industry
- Experience leading an IDE or pre-market study team
- Experience in Surgical therapies/product
- 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/or regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
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.
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