Contract

Medical Monitor (Remote)

SalaryCompetitive
LocationSan Diego, California, United States
SectorGeneral

Description

Summary

The successful candidate will be a qualified and motivated individual who will serve on cross-functional teams to further the development of our client’s drug for CNS disorders. This position reports to the SVP, Head of Clinical Development.

 

Primary Responsibilities

  • Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation and interpretation of clinical studies
  • Work closely with cross-functional colleagues to:
  • Design and author study synopses/protocols that will rigorously evaluate the therapeutic efficacy and patient safety
  • Medically monitor clinical studies, at all times focusing on quality and adherence to Good Clinical Practice
  • Continually evaluate study data, including trends analyses, protocol compliance, and issue identification
  • Interact frequently with sites to support study awareness, patient recruitment, and quality of study conduct
  • Utilize relevant metrics and other reporting tools to evaluate study strategy, tactics, deliverables and timelines, and recommend action plans for successful study completion.
  • Communicate appropriate study issues and results to key internal and external stakeholders.
  • Write and present final study reports
  • Support regulatory interactions, including the submission of regulatory documents and presentations.
  • Build productive relationships with investigators, key opinion leaders (KOLs), key stakeholders in the medical/scientific community, and internal cross-functional colleagues.
  • Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.
  • Promote a high performance culture and respectful work environment.
  • Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards.

Requirements:

  • Education/Experience/Skills:
  • MD (Medical Doctor or equivalent).
  • Board eligible/certified (neurology or psychiatry a plus)
  • Minimum 5 years of industry experience in clinical research/medical monitoring.
  • Demonstrated ability to work well within a geographically diverse team structure.
  • Strong communication and presentation skills.
  • Strong verbal and written command of the English language.
  • Highly motivated, self-driven and dependable.
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