at Sysmex America, Inc in Mundelein, Illinois, United States
Job Description
Project Manager, Clinical Hemostasis - TEMP
Job Location(s)
US-IL-Mundelein
# of Openings
1
Job ID
2024-3852
Category
Regulatory/Quality
Travel
None
Overview
Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.
Responsibilities
Reporting to the Director, Hemostasis, the Project Manager, Clinical Hemostasis is responsible for providing in-depth hemostasis experience and competitive industry knowledge, to assist the Director, while mentoring the Sr. Clinical Specialists.. The Project Manager will establish a core of Sysmex hemostasis product knowledge for existing and competitive products. The Project Manager, Clinical Hemostasis respects confidentiality of projects and conducts all initiatives with professional demeanor, within legal, regulatory and Sysmex standards. Demonstrates a positive attitude, strong interpersonal skills, organizational impact, and ability to manage projects and mentor people. This position will focus on the collection of technical data and design of the clinical studies, but will also have direct involvement with business to business aspects of the studies, working closely with the Director, Hemostasis and the rest of the Hemostasis Business Development Team. The Project Manager, Clinical Hemostasis will lead the effort to write protocols, implement and manage studies of Sysmex CN-series instruments and shall be responsible for multiple assays, while sharing responsibility for data collection, integrity, completeness, accuracy, legibility and analysis for preparation of FDA submission.
Essential Duties and Responsibilities:
1. The Project Manager, Clinical Hemostasis is the "go-to" expert on hemostasis pre-analytical and testing processes. Maintains professional, product and market expertise via independent reading, networking and training.
2. SME for principles & methodologies used in hemostasis instruments on market. The Scientist will be given formal opportunity to learn & is expected to build upon existing hemostasis testing knowledge to develop "hands-on" knowledge and skills in performing assigned assays. Becomes subject matter expert for Sysmex CN-series coagulation instruments, related applications and reagents.
3. Responsible for training site personnel on advanced operation and theory of the devices and clearly communicate specific study protocol requirements for assigned assays to ensure successful study performance.
4. The Project Manager, Clinical Hemostasis will work in concert with the Director, Hemostasis in development of and pre-clinical/clinical activities for hemostasis instruments and assays.
5. Responsible for multiple clinical trial processes and leads efforts to write clinical trial protocols and standard operating procedures relating to coagulation IVD products, and the clinical trial data collection.
6. Mentors the Senior Hemostasis Specialists for career growth. The Project Manager, Clinical Hemostasis shares clinical responsibility and will work closely with Project Manager, Hemostasis Business to review data collection, management, integrity, completeness, accuracy, legibility and analysis for preparation of FDA submission.
7. Provide clinical site troubleshooting support during clinical trial. Prepares responses and resolves queries to data collected as necessary.
8. Documents site compliance with the clinical protocol, GCP guidelines.
9. Support Regulatory Affairs team members by providing the clinical components for relevant submissions.
10. Other duties as required.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Percentage of Travel: Up to 0%, including short notice travel, as needed.
Qualifications
* Bachelor's Degree in Science, and 10 years Clinical Laboratory experience
* Additional advanced degree such as MBA is preferred
*... For full info follow application link.
