Clinical Study Management

  • location: Malvern, PA
  • type: Permanent
  • salary: $90,000 - $95,000 per year

job description

Clinical Study Management

Job Title: Medical Research Manager

Position Overview:

The Medical Research Manager will be a representative of the medical department who interacts with customers regarding Investigator Initiated Trials and Safety surveillance. The primary responsibility of this position is to provide scientific and clinical expertise support to both internal teams and external customers.

Essential Duties/Responsibilities:

Medical Research

  • Performs clinical literature research regarding psychiatric disease states

    • Summarizes key papers and review with key medical and other company personnel
    • Summarizes papers associated with studies for background
Safety

  • Oversees post market surveillance program through coordination of the safety committee to include:

    • Owner of agenda and minutes
    • Literature searches for safety surveillance
    • Coordination of medical complaints handling to closure
    • Clinical Evaluation Reporting
Clinical Development

  • Manages investigator initiated trial programs

    • Coordinates new proposals through review to completion
    • Interacts with investigators to discuss their research plan to understand and explain
    • Trains site to study responsibilities
  • Assists with sponsored clinical trial management activities
Other Duties

  • Provides support for Patient Assistance Program as requested.
  • Serves on the advertising and promotion committee, providing support to marketing with scientific input and expertise in the design of all advertising and promotional materials.
Knowledge, Skill, and Abilities:

  • Excellent written and verbal communication skills
  • Excellent interpersonal skills
  • Ability to multi-task
  • Customer-oriented and ability to work on cross-functional teams
  • Computer literacy is required (MS Office)
Education and Experience:

  • Bachelor of Science degree required; preferable in Life Sciences or Nursing
  • 5+ years of relevant Medical Information or Clinical Research experience
  • Proficient in medical information processes and industry standards
  • Medical Device or Pharmaceutical experience
Preferred Skills:

  • Experience with safety surveillance

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