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Medical Device Senior Clinical Research Specialist

Medical Device Senior Clinical Research Specialist

Overview

Canon USA’s Healthcare Optics Research Lab is working with leading medical institutions in the Boston area to develop medical imaging technologies. The Medical Device Senior Clinical Research Specialist (Sr Specialist Clinical Resrch) is part of Research and Clinical Translation team responsible for preclinical and clinical activities from research to product development. It is a hands-on role developing procedures and initiating preclinical and clinical testing plans for new diagnostic imaging and image guidance products.

Responsibilities

- Support development activities, especially the conduct of preclinical and clinical evidence gathering with different vendors and collaborators
- Responsible for defining, coordinating and performing tasks in preclinical development including protocol development, study conduct, and final reporting
- Participate in SOP development in support of a growing pre-clinical and clinical evidence function
- Support and coordinate clinical research activities with external collaboration, including study initiation, scheduled reviews, data and reports management
- As a core team member, collaborate with multi-functional team members to drive preclinical and clinical development strategies and plans
- Collect budget and time information from key sites and stakeholders to translate the feedback into executable plans
- Support clinical trial initiation and co-ordination with collaborating sites, including contract negotiations, site evaluation, protocol updates and edits, and where needed, CRO engagements for monitoring and data management
- Provides input into clinical evidence documents to ensure alignment with overall business strategy, including: protocols, pre-clinical study reports, clinical study reports, and processes for EUMDR documentation (such as the Post-Market Clinical Follow-Up Plans [PMCF]) and External Research Proposals (ERPs)

Qualifications

- 5+ years of preclinical/clinical development experience in an FDA regulated medical environment
- Clinical research experience working with CRO’s is a plus
- Basic understanding of biostatistics and clinical trial design. Experience with Minitab is a plus
- Proven track record of success at guiding preclinical and clinical development efforts
- Proficient in Microsoft Office suite. Experience with project management and Microsoft Project is a plus
- Science or engineering post-graduate degree is a plus
The company will not pursue or support visa sponsorship for this position.

Click https://external-canoncareers.icims.com/jobs/24041/senior-clinical-research-specialist/job to apply!

Company Overview

About our Company - Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2018† and is one of Fortune Magazine's World's Most Admired Companies in 2019. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com

Additional Info

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