RHO

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Medical Officer

Medical Officer

ID 
2017-1318
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Medical Officer will provide medical, clinical, and scientific advisory expertise across multiple therapeutic areas, to all Rho project teams, as requested. This position is responsible for interacting with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensure the scientific and ethical integrity of clinical trial design and conduct; provide medical input to clinical programs; and provide clinical development and regulatory input as needed.

Responsibilities

  • Serves as Medical Advisor on assigned projects.
  • Provides medical support to investigative sites and project staff for protocol-related issues.
  • Performs review and clarification of trial-related Adverse Events (AEs) and coding.
  • Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
  • Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Performs medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents such as marketing application, clinical safety/efficacy summaries and overviews.  
  • Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. 
  • Participates in the development of Medical Monitoring portion of client proposals including the budgeting process.
  • Supports Business Development activities by reviewing and providing medical/scientific input and guidance on Requests for Proposals (RFP), as well as by attending bid defense and other meetings with sponsors. Requires travel.
  • Reports to the senior medical officer and sector head.

Qualifications

  • A medical degree from a fully accredited (LCME or ex-US equivalent) medical school, along with an active state or provincial medical license is required.
  • In addition, a minimum of 5 years of experience in clinical medicine beyond residency and at least 2 years of clinical development experience are required in the drug development or Biotech industries, or as a principal investigator on clinical trials.
  • Specialty board certification is required.
  • Good understanding of general clinical medicine; knowledge is not restricted primarily to a specialty area.
  • Good understanding of research methodologies and clinical trial design, including biostatistics.
  • Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines.
  • Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives.
  • Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
  • Ability to establish and maintain cooperative and effective working relationships with coworkers, managers and clients.

 

EOE. Veterans/Disabled