Clinical Project Leader

2 months ago

newark, United States GForce Life Sciences Full time

Summary

Our client, a global medical device & diagnostic manufacturer has engaged GForce Life Sciences to identify a hands-on Clinical Project Leader (CPL) to join and own the overall responsibility to define and implement the safety and efficacy (S&E) requirements for their product portfolio. The position is also responsible for designing and interpreting results of feasibility testing, and clinical studies and human factors studies. Additionally, the CPL provides medical, scientific, and technical leadership and perspectives to project teams and other functions such as Regulatory, Marketing, Research & Development, and Quality. This position is responsible for identifying, developing and /or evaluating current / new technologies and customer solutions in scientific disciplines within and outside of the traditional clinical laboratory. The CPL initiates and coordinates liaisons with internal/external medical, academic, regulatory and industry individuals or groups in support of business needs. The position also generates and communicates clinical and technical information that may support innovation strategies, technology and product development, and product lifecycle management for marketed products. In support of all currently marketed products, the CPL provides technical support, associate education, troubleshooting, and competitive assessments.


Duties / Expectations of Role

· Reviews information and assesses risks related to vendor, material, and manufacturing process changes. Designs clinical studies as needed and interprets and presents results.

· Designs studies, formulates and conducts scientific investigations, feasibility studies, and due diligence studies related to new technologies and current products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and presents at scientific meetings or within BD

· Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in specimen management and other related technologies. Communicates findings and interpretations to teams and management

· Represents Medical Affairs in areas that may involve innovation, technology development, product development and product lifecycle management teams. Senses and defines key trends and unmet needs in science, technology, medical practice, and health economics.

· Provides customer and product knowledge to team. Develops safety and efficacy requirements and a clinical test plan to address S&E, Regulatory and Marketing requirements for new and improved products and gains functional approval of such.

· Works with the team to identify and evaluate new opportunities and present such to business leaders following the formal Innovation process. Ensures safety, efficacy and clinical utility of the product, technology, and related labelling/promotional material.

· Interacts with global medical, academic and industry experts to establish strategic direction for innovation, technology, and product development projects.

· Provides clinical support to products entering or currently on the market including training BD associates, troubleshooting, data review, interpretation and presentation, post market study design, publications, preparation or review of regulatory communications, and addressing quality issues.

· Provides medical expertise and leadership for Human Factor Engineering (HFE) studies, Health Economics & Outcomes Research (HEOR) studies, post-market surveillance and post-market studies.


Mandatory Requirements

• BS in a health-related field

· 2+ years of hospital / reference clinical laboratory or related healthcare field experience, or clinical research

• Understanding of clinical studies and study design

· Medical technology experience is highly preferred

• Knowledge of scientific methodologies and clinical laboratory medicine

• Knowledge of material changes, process changes, and product lifecycle management

• Knowledge and understanding of product development

• Ability to understand, interpret and explain clinical and scientific information.

• Ability to work in a fast-paced environment.

Nice to Have Requirements

• MS in a health-related field

• MT(ASCP) or equivalent is desirable

· 2+ years of clinical studies and study design

· Experience in a medical device/IVD company is a plus.

Term & Start

· 1 year contract with potential to convert to full time

· Start ASAP

· Full Time

· Benefits included (Medical, Dental, Vision, 401k)

· Hybrid – NJ. Onsite 2-3 days a week.

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