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Medical Monitor

System One Princeton Full-Time
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Position Title: Medical Monitor
Location: Princeton, New Jersey
Duration:  Permanent  
Start Date:  Immediate
Salary:  Competitive salary offered with full benefit package

Responsibilities:

  • Lead strategic planning for clinical development programs
  • Develop clinical synopsis, protocols and amendments, investigator brochures, and clinical study reports
  • Lead clinical study team and provide appropriate medical monitoring for clinical studies
  • Evaluate pharmacology, safety and efficacy data from ongoing and completed studies
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Be medical resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines
  • Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility
  • Interact with key opinion leaders related to assigned compounds and therapeutic area
  • Contribute to NDA and MAA filings and prepare relevant sections of the regulatory documents

Requirements:

  • MD or MD/PhD
  • At least 2-5 Years Industry Experience in Clinical Development
  • Clinical practice experience; Board certification, neurology or psychiatry preferred
  • Strong leadership skills, and ability to lead clinical team and work effectively with cross functional teams and leaders
  • Superior communication, interpersonal and negotiating skills to interact with internal leadership team, external partners and investigators/medical professionals
  • Team spirit
  • Global perspective and mindset, ability to work effectively with colleagues from myriad cultures, backgrounds and geographies
  • Ability to proactively look into issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Knowledge in FDA, EMA, JMPD and other regulatory requirements, GCP/ICH
  • Ability to travel up to 20% for meetings or study site visits, including overnight and some international trips

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

 

Recommended skills

Non Disclosure Agreement (Intellectual Property Law)
Clinical Study Reports
Good Clinical Practices (Gcp)
Pre Clinical Development
Decision Making
Business Development

Location

CareerBuilder Estimated Salary

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$92K
Below Avg. Average Above Avg.
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Job ID: BHJOB18630_145604

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