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Clinical Trial Manager

Company: Elysium Health
Location: New York
Posted on: June 14, 2018

Job Description:

Elysium is seeking a Clinical Trial Manager. In this position, you will be an essential part of our research team focused on promising areas of consumer health with our scientific advisory board and research partners at leading academic institutions. You will be directly responsible for managing clinical studies in both healthy populations and therapeutic indications. Specifically, you will lead the protocol development, site selection, budget determination and scheduling of monitoring activities. At Elysium, our mission and goal is to solve the most challenging aspects of health. Join our team of exceptional scientists, doctors and researchers focused on solving the most challenging and important aspects of health.

Responsibilities

You will:

  • Develop and manage study budgets and deliverables through collaboration with internal and external stakeholders
  • Drive study execution and develop performance metrics and quality indicators
  • Oversee clinical monitoring activities and adherence to established processes and plans
  • Proactively identify potential risks and issues
  • Determine and implement solutions to balance study budgets and deliverables
  • Maintain forecasts and inform executive leadership on overall progress of studies
  • Develop and manage vendor's scope of work
  • Provide operational and strategic input into study documents
  • Oversee investigational product supply forecast
  • Lead contract research organization and site selection processes
  • Identify and coordinate bioanalytical testing when necessary
  • Participate in the serious adverse event reconciliation process
  • Develop and use standardized reports to share information with key internal and external stakeholders
    Leadership

    You must:
    • Create realistic plans that clearly define goals, responsibilities and results
    • Maintain focus on strategic objectives while accomplishing operational goals
    • Place a priority on getting results with an emphasis on high quality outcomes
    • Make timely and data-driven decisions
    • Encourage collaboration across teams, functions and geographies
    • Ensure that conflict is handled constructively so that performance is not impacted
    • Display a willingness to challenge the status quo and take risks
    • Respond resourcefully to changing business demands and opportunities
    • Maintain optimism and composure in times of change, uncertainty or stress
    • Recognize and reward team accomplishments
    • Possess a strong sense of urgency that drives performance beyond expectation
      Requirements

      You have:
      • BA/BS in life sciences or related discipline
      • Minimum 5 years of clinical trial experience
      • Minimum 2 years of management experience
      • Experience managing contract research organizations
      • Current knowledge of FDA regulations for IND clinical trials
      • Advanced knowledge of GCP/ICH and local guidelines, regulations and directives
      • Time management skills with the ability to effectively multi-task and prioritize
      • Proven problem solving and decision making skills
      • Excellent oral and written skills with the ability to effectively communicate complex topics

        About Elysium

        Elysium Health's mission is to solve the biggest challenges in health with science, to help people live healthier for longer. Elysium works directly with top scientists, clinicians and health professionals around the world to translate advances in science and technology into innovative health products that work. Our product development pipeline begins with research and development, continues with preclinical studies, and culminates with human clinical trials to demonstrate the safety and efficacy of products. Throughout this process, Elysium's focus is to develop compounds found in nature that allow people to support their health proactively.

        Elysium is guided by a Scientific Advisory Board, which includes multiple winners of the Nobel Prize, as well as researchers and doctors who are experts in chemistry, physiology, neuroscience, complex chemical systems, biochemistry, and many other fields of study.

        Basis, Elysium Health's first product, is a proprietary formulation of two ingredients designed to support long-term health at the cellular level. Basis is clinically proven to increase NAD+ levels, which decline with age. NAD+ is required for energy creation, regulating circadian rhythms, maintaining healthy DNA, and hundreds of other biological functions.

        We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

        Keywords: Elysium Health, New York, Clinical Trial Manager, Healthcare, New York, New York

        Click here to apply!

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