Ascensia Diabetes Care is a global diabetes care company, dedicated to helping improve the lives of people with diabetes by empowering them to take charge of their health. At Ascensia, we want to serve the needs of patients through our innovation and specialist expertise in diabetes. We create high quality solutions and precision tools that help patients manage their condition. Innovation is in our DNA and we are agile, entrepreneurial and dynamic in the way we operate.
Act as Study Manager to assure compliant and scientifically sound clinical trials to support new and modified products from Ascensia Diabetes Care
Facilitate the planning, implementation, and timely completion of external and internal clinical trials, as required by regulatory and registering bodies, that confirm excellence of product performance, while providing publications and other needed product support materials.
LOCATION: Valhalla, NY
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Represent Global Clinical Affairs (GCA) on selected product development teams and within the teams, assist with product development and design of clinical study plans and protocols to assess performance, claims and other attributes of product design.
The Clinical Research Scientist will assist with the following: write protocols, identify clinical sites, negotiate budgets, develop case report forms, ensure IRB approval, ensure compliance with all Federal regulations and good clinical practice (GCP), manage and monitor studies, ensure appropriate data management and analysis, write the clinical trial reports for technical reviews, regulatory submissions and white papers.
This person is responsible for assisting to development of the overall Clinical Trial Plan for new and modified diabetes care products. This is accomplished with input from the project team and statistician and with oversight from GCA management.
The incumbent must be able to work independently as well as in a team situation and require minimal supervision or oversight. In addition, this person must be able to function effectively on several projects simultaneously with aggressive timelines.
Work with CROs to oversee clinical trials that are in compliance with Ascensia Diabetes Care policies and Good Clinical Practices.
Facilitate the completion of reports for technical reviews, 510(k)s, PMAs, regulatory body submissions.
Assist with whitepapers, abstracts, poster presentations and publications in peer reviewed journals.
Participate in the writing of manuscripts for publication in scientific journals in cooperation with the investigators and GCA management, and for presenting findings at scientific meetings.
Develop working relationships with external experts/opinion leaders.
Proven experience in the clinical research area: three (3) years with a BS, two (2) years with an MS, or one (1) year with a PhD or
Ability to manage clinical studies, including protocol and report writing, study monitoring and Technical expertise in diabetes, blood glucose monitoring is desired.
Interest and capability in clinical research, blood glucose monitoring, laboratory science and medicine, outcomes research, experimental design, statistical methods, product development and use of diagnostic products, desired.
The Clinical Research Scientist should have an understanding of scientific principles to assure effective and high-level study design and data analysis.
Ability to handle significant workloads, aggressive timelines, work effectively with peers in teams; work effectively with minimal supervision.
Excellent written and oral communication skills. Excellent computer skills: MS Office programs, spread sheets, graphics/statistics, presentations.
Experience with Electronic Data collection (EDC) is desired.
Travel: Ability to travel approximately 20% of time domestically.
Internal Number: MED0018
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.