|Location||New Jersey, United States|
Clinical Study Manager
The client 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. They 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.
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 lead the design of clinical study plans and protocols to assess performance, claims and other attributes of product design.
- The Clinical Manager will design and write protocols, identify clinical sites, negotiate budgets, oversee development of case report forms, ensure IRB approval, ensure compliance with all Federal regulations and good clinical practice (GCP), manage and oversee monitoring of studies, ensure appropriate data management and analysis, write the clinical trial reports for technical reviews, regulatory submissions and white papers.
- This person will manage clinical research or outcomes studies for new or existing products, develop protocols, identify external research sites and negotiate study budgets with investigators.
- This person is responsible for the 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 the company’s policies and Good Clinical Practices.
- Write reports for technical reviews, 510(k)s, PMAs, regulatory body submissions.
- Prepare 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 with experience in CGM development and clinical studies: ten (10) years with a BS, eight (8) years with an MS, or five (5) years with a PhD or PharmD.
- Ability to manage clinical studies, including protocol design and report writing, study monitoring and management.
- Technical expertise in diabetes, blood glucose monitoring and CGM experience is required.
- 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 Study Manager 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 working with CROs is strongly desired.
- Experience with Electronic Data collection (EDC) is desired.
- Travel: Ability to travel approximately 20% of time.