Clinical Trial Manager

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 is building the world's first direct-to-consumer health science company, developing advanced natural products that go beyond nutritional and dietary supplements to address cellular health at the most fundamental levels. Using new technologies, we can now impact wellness at an unprecedented scale - from cellular and metabolic processes to entire systems and pathways. We are growing our operational team to work with over 30 scientists and medical pioneers, as well as 7 Nobel Laureates, to bring scientific breakthroughs in health directly to the home.

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.
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