Senior Clinical Research Specialist (Clinical Scientist) - Onsite
MedtronicAbout the role
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
As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.
Our Neurovascular operating unit advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. With devices designed for revascularization, embolization, and precise intervention, we support clinicians in delivering timely, effective care for complex neurovascular conditions.
Check us out on LinkedIn: Medtronic Neurovascular
Provides oversight and leadership for the design and implementation of Global clinical development activities in support of specific programs within the Neurovascular portfolio. Specifically, this critical position will lead clinical science and writing activities for the assigned new product development programs, design clinical strategies for regulatory approvals and market access for NV products, and manage the evidence life cycle for the NV portfolio.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
Accountable for driving and overseeing the assigned clinical strategy initiatives – working closely with Clinical Operations and the Biostatistics lead for the assigned clinical trial(s) to ensure the overall success of the program
Plays an active role in reviewing ongoing study progress and leading certain aspects of data-readiness workstreams within the assigned clinical trial(s)
Sets a 3-5 year vision and strategy for comprehensive clinical evidence strategies that position the overall portfolio for long-term success
Strategic thought partner within the assigned therapy franchise, partnering with the leaders of Clinical research, Regulatory, R&D, Quality, and Marketing in the development of high-quality, efficient, and innovative clinical programs
Assist/leads steering committee meetings/physician advisory boards, and discussion forums to gain a deeper understanding of evolving therapeutic space, and for input into clinical development plans
Leads and mobilizes the creation of clinical documents, including but not limited to clinical research protocols, clinical study reports, clinical evaluation reports, and clinical marketing materials
Accountable for establishing and monitoring high-performance standards and metrics for the assigned portfolio
Review and provide clinical feedback on the assigned External Research Projects
Partner with the Quality and Compliance Office as needed to identify and mitigate quality and compliance risks
Collaborates with cross-functional teams, such as marketing, sales, clinical, R&D, HE&R, Quality, Compliance, and Regulatory
Ensures seamless interaction and knowledge transfer with international colleagues
Manages physician faculty and continues to develop key relationships with KOL’s
Provides guidance to ensure that all necessary clinical sciences activities are in governmental and Medtronic quality compliance always, including, but not limited to, ACCME, AdvaMed, ISO 9001, FDA regulations, and QSR(GMP) standards
Develops and cultivates strong relationships with key academic institutions, hospitals, scientific societies, and associations to facilitate evidence generation and KOL development
Oversees the implementation of policies and procedures
Required Knowledge and Experience:
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