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.
Under the supervision of Ascensia’s Director of Sensor Technology, the Internal Clinical Trials Manager leads the internal clinical program, including SOPs and processes, training new hires and ensuring compliance to GCP/GLP. The internal clinical program is a key asset to Ascensia Diabetes Care by providing data for algorithm development, regulatory submissions and product surveillance. In addition, the incumbent will provide technical insights into product and system performance, analyzing data and presenting results to fellow scientists.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Plan and direct internal clinical studies.
Ensure compliance with Good Clinical Practice.
Ensure subject safety and privacy of subject data.
Plan, coordinate, and execute experiments relating to the development of new products.
May represent R&D on cross-functional program teams.
Direct staff who execute clinical studies and laboratory experiments.
Communicate with related functions the results of internal clinical and laboratory studies.
Analyze data and prepare reports, product development reviews, product manuals and regulatory submissions.
Verify performance of devices and systems for milestone reviews in stage-gate product development process.
Evaluate performance of internally derived and OEM technology.
Investigate marketed products to determine which innovations could have a significant impact.
May contribute to posters, presentations and white papers for publications and professional conferences.
Comply with requirements for workplace safety and intellectual property protection.
BS with 12 years of proven experience and accomplishments, OR
MS with 10 years of proven experience and accomplishments, OR
PhD with 8 years of experience and accomplishments.
5 years of experience in the medical device or pharmaceutical industry.
5 years of experience coordinating or managing clinical trials.
Clinical research certification (e.g., ACRP, CRS, SOCRA) preferred
Or if non-degreed, 15 years proven performance experience
The incumbent must be able to manage multiple priorities of both a technical and nontechnical nature.
The incumbent must demonstrate expert technical skills and mastery of scientific and research principles.
The incumbent must have the ability to train others.
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.
Ascensia is an Equal Opportunity Employer.
Job Type: Full-time
managing or coordinating clinical trials: 5 years
people management: 2 years
scientific or technical: 1 year
Required license or certification:
Clinical Research Certification
Ascensia Diabetes Care