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Clinical Project Lead
4 months ago
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 a new product. The position is also responsible for designing and interpreting results of feasibility, and clinical and human factors studies. Additionally, the CPL provides medical, scientific, and technical leadership and perspective to project teams and other functions such as Regulatory and Quality. This position is responsible for identifying, developing and /or evaluating 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 to 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
- Represents Medical Affairs in the 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.
- Reviews information and assesses risks related to vendor, material and manufacturing process
- changes. 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.
- 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.
- 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 associates, troubleshooting, data review, interpretation and presentation, post market study design, publications, preparation or review of regulatory communications, and addressing quality issues.
- Designs studies, formulates and conducts scientific investigations, feasibility studies, and due diligence studies related to new technologies and products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and presents at scientific meetings.
- Reviews information and assesses risks related to vendor, material, and manufacturing process changes. Designs clinical studies as needed and interprets and presents results.
- 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 clinical laboratory or related healthcare field experience, or clinical research
- Medtech 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
- Understanding of clinical studies and study design
- Ability to understand, interpret and explain clinical and scientific information.
- Ability to work in a fast-paced environment.
Nice to Have Requirements
- BS or MS in a health-related field
- MT(ASCP) or equivalent is desirable
- Experience in a medical device/IVD company is a plus.
Term & Start
- 1-year contract with the potential to convert to full-time
- Start ASAP
- Full Time
- Benefits included (Medical, Dental, Vision, 401k)
- Hybrid - Franklin Lakes, NJ. Onsite 2-3 days a week.
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