Sr Clinical Research Spec

**Careers that Change Lives**
The position will be opened during a phase where our operating unit move from Medtronic to a to-be-named company we are calling “NewCo”. NewCo will be an independent company with equal partners, Medtronic & DaVita. It will be established in calendar 2023 as a new company (NewCo) formed from Medtronic’s Renal Care Solutions Operating Unit focused on providing innovative technologies to support kidney care patients.

NewCo is uniquely poised to transform renal care and dialysis, building on Medtronic’s innovation and technology pipeline. The business will have the singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable life-saving renal care technologies — particularly our transformative home dialysis platform technologies.

**A Day in the Life**
**As Sr Clinical Research Specialist, **you will be working within the Scientific Affairs department, which is part of the larger Clinical Research Medical Science group. This is an exciting global position in clinical research that covers the field of extracorporeal blood purification (chronic therapies such as hemodialysis and acute therapies such as renal replacement therapies in the intensive care units).

You will play a key role in the strategy, design and management of clinical studies and provide clinical support and guidance to our internal multifunctional team including regulatory affairs, quality, R&D and marketing/commercial.

You will report to the Sr. Medical Affairs Manager based in Mirandola Italy

**Main Responsibilities include**:

- Oversees, designs, and manages clinical studies including sponsored pre
- and post-market studies
- Prepares and authors protocols and patient record forms
- 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
- Prepares and authors final study reports
- Works in collaboration with regulatory affairs for supporting documentation regarding clinical activities and regulatory submissions
- Provides clinical input regarding all phases of the product lifecycle
- May be involved in product discussions with clinicians and advisory boards
- Participation and representation of the company at congresses

**Must Have**
- Bachelor’s degree in science or Engineering field
- 4 years of clinical research or regulatory affairs experience, preferably in the medical device field
- Fluent in English
- Ability to travel (