Project Manager, Clinical Hemostasis - Mundelein, United States - Sysmex

Description

Overview:

Find a Better Way...

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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.

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.

build a promising future.

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.

Bachelors Degree in Science, and 10 years Clinical Laboratory experience
Additional advanced degree such as MBA is preferred
Comprehensive medical lab knowledge w/ emphasis in hemostasis & good foundation in other laboratory testing methodologies across other departments.
Technical expert in hemostasis
CRA or PMP experience (and/or certification) is desirable.

Documented prior/current State Licensure and/or Certification as MLS/CLS/MT/MLT or equivalent. (This includes HEW-qualified clinical technologists as defined by CLIA.)

Demonstrate skills and knowledge typically developed over a minimum of 6 years of product/assay/service development or clinical trial experience that includes at least 4 years project/team leadership.
Experience closely monitoring instrument/assay performance and/or clinical trials.
Technical laboratory instrument expertise/experience with Hemostasis and IA.
Knowledge of clinical laboratory regulations and familiarity with industry standards related to implementation and/or regulatory clearance of IVD devices and reagents kits.

Excellent verbal and written communication in English language
Strong interpersonal skills, ability to work independently yet interface effectively with all levels of staff and management, both internally and externally.
Able to create written Technical training documents, laboratory SOPs & executive summaries.
Second language French, Spanish or Portuguese helpful to support non-US locations w/in SAI

Master of internet communication tools ZOOM, TEAMS, Outlook email & scheduling, etc.
Excel Spreadsheets, Word, Microsoft Suite, PowerPoint.
Laboratory &/or LIS computer skills are a plus.

Word Processing, Spreadsheets with formulas, graphing and basic statistics.

Laboratory &/or LIS computer skills would be a plus.
Must have or be able to obtain Passport for international travel
Excellent organizational skills, and attention to detail.
Ability to manage multiple priorities.

This job requires satisfaction of the credentialing requirements of Sysmexs customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19. Further, Sysmexs COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individuals ability to provide proof of current vaccination status to the extent permitted by applicable law. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job including working at customer locations.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.