Researcher / analyst
Careers that Change LivesWithin the Minimally Invasive Therapy Group (MITG), we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust. Our constant focus on innovation, combined with significant investment in research and development, ensures that we will continue to introduce new technologies that have the potential to "disrupt" today's standard methodologies and open new business opportunities Whatever your specialty or ambitions, you can make a difference within the Minimally Invasive Therapy Group (MITG) & Medtronic - both in the lives of others and your career. A Day in the LifeWithin EMEA the MITG Clinical Affairs Department plays a strategic role in deciding an effective clinical program for all MITG therapeutic areas. The objective is to produce credible medical-scientific evidence to enable informed decisions on the management of identified disease states. Overview
- Coordinates the Regional External Research Program (ERP) Review committee meeting for the allocated business and collaborates with the Global ERP review committee
- Manages allocated MITG External Research Programmes (ERP) in EMEA throughout their entire life- cycle from initial submission, approval process, contract negotiation, active Study, budget management, device return and publication.
- Collaborate with global and regional medical affairs colleagues, on the strategic pathway of specific therapeutic area/disease states
- Collaborate with Clinical Affairs colleagues in the conduct of clinical trials of medical devices
- Logistically manages the coding, shipment and return of devices.
- Maintains Trial Master Files in Vision Tracker of all assigned ERPs.
- Ensures compliance with applicable quality and regulatory standards.
- Assists in development of internal clinical affairs operating procedures and policies in relation to ERP process
- Responsible for reporting and presenting on ERPs to all stakeholders as appropriate.
- Responsible for KOL management in relation to ERPs
- Review assigned marketing material for clinical accuracy and scientific rigor
- Ensures the successful and timely execution of clinical milestones
- Complies with applicable quality and regulatory standards
- Ensures achievement of MITG Clinical Affairs departmental objectives on time and on budget
- Adhere as appropriate to GCP, ISO14155 guidelines and Medtronic Standard Operating Procedures in order to meet the needs of all Medtronic Business Units
- Proven experience in clinical research, preferably in the Medical Device Industry.
- Proficient knowledge of medical terminology
- Expertise with ISO14155, GCP and regulatory & compliance guidelines for clinical trials
- Ability to work in a diverse team environment and with global and International teams and to adapt to changing priorities
- Ability to identify problems, develop and implement solutions to address study issues.
- Ability to work with a minimum of supervision.
- High attention to detail and accuracy
- Advanced written and oral communication skills
- Able to manage multiple tasks independently
- Willingness and ability to travel overseas 20 to 40% of the time.
- Advanced written and spoken English.
Nice to Haves Your Answer About MedtronicTogether, 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.Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.
Change Begins With You
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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.
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