Clinical Project Leader

2 months ago

Franklin Lakes, 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.

  • Clinical Project Leader

    4 weeks ago

    Franklin Lakes, United States Insight Global Full time

    About the Company - Insight Global is looking for a Clinical Project Leader to support one of our Fortune 500 Medical Device clients in Franklin Lakes, NJ.Duration: 12-month contract (possible perm & exts.)Interview Process: 2 round virtual interviewPay range: up to $59.50/hr About the Role - This person will be responsible for designing studies,...

  • Clinical Project Leader

    4 weeks ago

    Franklin Lakes, United States Insight Global Full time

    Insight Global is looking for a Clinical Project Manager to support one of our Fortune 500 Medical Device clients in Franklin Lakes, NJ. This person will be responsible for designing studies, formulating, and conducting scientific investigations, feasibility studies, and due diligence studies related to new technologies and current products. They will be...

  • Clinical Project Manager

    4 weeks ago

    Franklin Lakes, New Jersey, United States Insight Global Full time

    About Insight Global - We are seeking a highly skilled Clinical Project Leader to support one of our Fortune 500 Medical Device clients in New Jersey.Duration: 12-month contract with potential for extension.Interview Process: Virtual interviews with two rounds.Compensation: Up to $59.50 per hour.About the Role - This individual will be responsible for...

  • Clinical Lab Specialist

    2 months ago

    Franklin Lakes, United States MILLENNIUMSOFT Full time

    Hello There, We at Millenniumsoft looking for Clinical Lab Specialist & Clinical Lab Assistant /Sample Processor with5 years’+ experience in clinical laboratory science or in clinical research, product investigations, troubleshooting abnormal laboratory results and product development with clinical trials’ experience desired.   Job Title – Clinical...

  • Senior Marketing Project Manager

    4 weeks ago

    Franklin Lakes, New Jersey, United States MILLENNIUMSOFT Full time

    Job Title: Senior Marketing Project ManagerLocation: Franklin Lakes, NJContract Term: 6+ MonthsWeekly 40.00 Hours [Mon - Fri]Description:Key Responsibilities:• Develop and execute marketing strategies to support new product launches• Lead project/initiative teams to achieve key marketing functional projects• Manage marketing activities, including...

  • SAP ERP Project Manager

    3 weeks ago

    franklin lakes, United States Amerit Consulting Full time

    Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an SAP ERP Project Manager_______________________________________________NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)*** Candidate must be authorized to work in USA without...

  • SAP ERP Project Manager

    3 weeks ago

    Franklin Lakes, United States Amerit Consulting Full time

    Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an SAP ERP Project Manager_______________________________________________NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)*** Candidate must be authorized to work in USA without...

  • Clinical Data Manager

    5 days ago

    franklin lakes, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget. Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated. Manage interactions and deliverables...

  • Clinical Laboratory Specialist

    1 month ago

    Franklin Lakes, New Jersey, United States Insight Global Full time

    Job Title: Clinical Laboratory SpecialistInsight Global is seeking a highly skilled Clinical Laboratory Specialist to join our team in Franklin Lakes, NJ. This role will involve designing, evaluating, executing, and reporting on the safety and efficacy of in-vitro diagnostic devices.Key Responsibilities:Conduct clinical testing and manage laboratory studies...

  • Clinical Laboratory Specialist

    4 weeks ago

    Franklin Lakes, New Jersey, United States Insight Global Full time

    Job Title: Clinical Laboratory SpecialistJob Summary:Insight Global is seeking a skilled Clinical Laboratory Specialist to join our team. The ideal candidate will have a strong background in clinical laboratory science and experience in testing medical instruments and processing specimens.Key Responsibilities: Design, evaluate, execute, and report on the...

  • Clinical Leader for Behavioral Health

    4 weeks ago

    Franklin, Tennessee, United States Fast Pace Health Full time

    Job TitleSupervising Psychiatrist (AL or Compact Multi-State)OverviewFast Pace Health is seeking a highly skilled and experienced Supervising Psychiatrist to join our team. Our ideal candidate will be deeply committed to nurturing our mission of teamwork, communication, empowerment, and quality care in a friendly and encouraging environment.We aim to push...

  • Senior Psychiatrist Leader

    1 month ago

    Franklin, Tennessee, United States Fast Pace Health Full time

    Leadership OpportunityFast Pace Health is seeking a highly skilled and experienced Senior Psychiatrist Leader to join our team. As a key member of our leadership team, you will be responsible for supervising mid-level providers and ensuring the delivery of high-quality patient care.Key ResponsibilitiesSupervise mid-level providers at our clinics, ensuring...

  • Strategic Change Management Leader

    4 weeks ago

    Franklin, Wisconsin, United States NORTHWESTERN MUTUAL LIFE INSURANCE Full time

    Job Summary:As a Strategic Change Management Leader at Northwestern Mutual Life Insurance, you will be responsible for leading large-scale change initiatives that drive business outcomes and benefits. This role requires a strong understanding of organizational change management principles and the ability to develop and implement integrated change strategies...

  • Project Manager

    3 weeks ago

    Franklin, United States Servpro Industries, LLC Full time

    What we offer Excellent health benefits plan, which includes medical, vision and dental options 401(k) with company match Company profit sharing plan Generous paid time-off and paid holidays Paid parental leave Company-paid mental health benefit through Headspace 2 free on-site fitness rooms Employee Assistance Program Employee Resource Groups ...

  • Construction Superintendent

    2 weeks ago

    Franklin Lakes, United States Michael Page Full time

    p>This New Jersey-based construction company is a leading General Contractor, established more than 20 years ago. They are a leader in the New Jersey market with a track record of excellent clients and a strong pipeline of diverse commercial projects. They specialize in various commercial sectors and are known for their employee satisfaction and fantastic...

  • Pharmacy Technician

    4 weeks ago

    Franklin, Tennessee, United States Clinical Solutions LLC Full time

    Job DescriptionWe are seeking a highly skilled and detail-oriented Part Time Order Entry Pharmacy Technician CPhT to join our team at Clinical Solutions Pharmacy. As a Pharmacy Technician, you will play a vital role in ensuring the accuracy and efficiency of our order entry process.Key Responsibilities:Courteously assist all internal and external...

  • Order Entry Pharmacy Technician CPhT

    1 month ago

    Franklin, United States Clinical Solutions LLC Full time

    We are growing! Clinical Solutions Pharmacy is looking for ambitious, impactful, goal-oriented Order Entry Pharmacy Technicians CPhT to join our Order Entry Team. If you enjoy working in a closed-door pharmacy setting, we encourage you to apply! Clinical Solutions Pharmacy is the only 100% female owned and founded closed-door pharmacy in the United States...

  • Financial Analyst(Must Have SAP, Hyperion

    3 weeks ago

    Franklin Lakes, United States MILLENNIUMSOFT Full time

    Position       : Financial Analyst(Must Have SAP, Hyperion & BPC) Location : Franklin Lakes, NJ Duration : 12 Months Contract Total Hours/week : 40.00 1st shift Must Have : Approximately 5 to 8 years’ experience Proficient in Excel Proficient in Financial Systems (SAP, Hyperion, BPC a plus) Project Management...

  • Marketing Director, US Region

    4 weeks ago

    Franklin Lakes, New Jersey, United States BD Full time

    Job Description SummaryBD is a global medical technology company that advances the world of health. As a Marketing Director, US Region, you will play a critical role in supporting revenue and margin growth of ~$10B in combined US Region products and services through the development and execution of comprehensive ONE BD value offers and solutions.The position...

  • Project CNO

    2 months ago

    Franklin, United States Community Health System Full time

    Job Description Community Health Systems is one of the nation's leading healthcare providers. Developing and operating healthcare delivery systems in 39 distinct markets across 15 states, CHS is committed to helping people get well and live healthier. CHS operates 69 acute-care hospitals and more than 1,000 other sites of care, including physician...