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Senior Medical Director (Neurologist) - Remote

Allucent

New Remote
Remote Senior 🇬🇧 English
MedDRA WHO coding Word Excel PowerPoint

Job description

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials. It is looking for a board-certified neurologist to join its A-team remotely as Senior Medical Director. You will work independently to safeguard the medical, clinical and safety integrity and quality of trials, acting as the medical monitor contact for investigators and study sites on protocol and safety questions.

Key responsibilities

  • Provide independent medical monitoring support for assigned studies, answering medical questions from the study team and sites and reviewing clinical laboratory data and case report forms
  • Prepare medical monitoring and other study plans before each study starts, according to contractual deliverables
  • Review serious adverse events, SUSARs, safety narratives and perform analysis of similar events
  • Assist clinical data management with MedDRA and WHO coding
  • Review clinical study documents (protocol, informed consent, CSR, DSUR, PSUR) for medical consistency
  • Assist in setting up and running Data Safety Boards and dose escalation meetings
  • Attend kick-off, investigator and other project meetings, and give 24/7 urgent medical advice when needed
  • Train project teams on the medical aspects of the trial and review protocol deviations
  • Identify study risks, review medical deliverables and track study budgets
  • Present at major therapeutic and drug development conferences, maintain client relationships and take part in client evaluations, visits and bid defenses

Required profile

  • MD degree and board certification as a neurologist
  • Minimum 7-9 years of relevant experience with solid neurology expertise
  • Experience as a neurologist treating Alzheimer's disease and Parkinson's disease; other neurology and psychiatry experience is a key asset
  • Good standing with local, state (in the US) and national licensing and regulatory authorities
  • Outgoing, representative and client-focused, able to work in a fast-paced environment

Required skills

  • Good knowledge of GxPG
  • Understanding of GDPR/HIPAA, CFR/CTR/CTD and applicable regulatory requirements
  • Proficiency with Word, Excel and PowerPoint

What we offer

  • Comprehensive benefits package and competitive salary per location
  • Departmental study/training budget and flexible working hours
  • Remote or hybrid work depending on location, with 2 days in the office per week for nearby employees
  • Leadership, mentoring and internal growth opportunities
  • Buddy program, employee referral program, spot bonus and loyalty award programs

Questions fréquentes

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Source : ats:workable

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Published 17 hours ago

Expires 1 month from now

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