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.
POSITION PURPOSE: 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.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Represent GCA/GMCA 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 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 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.
Consult with and advise other groups (such as Ascensia R&D, QA, Ascensia partner companies) who conduct human studies, as well as Ascensia groups who conduct clinical studies outside of the US.
Work with CROs to oversee clinical trials that are in compliance with Ascensia Diabetes Care policies and Good Clinical Practices.
Complete reports for technical reviews, 510(k)s, PMAs, regulatory body submissions, 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.
Provide ongoing clinical support for portfolio issues that arise after product launch and at any time during the product lifecycle.
Proven experience in the clinical research area: six (6) years with a BS, four (4) years with an MS, or two (2) years with a PhD or PharmD.
Proven ability to manage clinical studies, including protocol and report writing, study monitoring and management. 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.
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.
YOUR APPLICATION: Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer.
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes.