Associate Director, Medial Monitoring

  • location: Princeton, NJ
  • type: Permanent
  • salary: $180,000 - $200,000 per year
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job description

Associate Director, Medial Monitoring

job summary:
**IMMEDIATE NEED for an Associate Director/Director, Medial Monitoring in the Princeton, NJ area. Must be an MD or PharmD, be able to speak Mandarin, and have 3-5 years of experience in Medical Monitoring.**

 
location: Princeton, New Jersey
job type: Permanent
salary: $180,000 - 200,000 per year
work hours: 9 to 5
education: Doctorate
 
responsibilities:
  • Leads development of clinical sections of trial and program level documents (e.g., clinical synopsis, protocols and amendments, Investigator's Brochures, safety updates, submission dossiers, and responses to Health Authorities).
  • Medical support to the clinical study team and provide appropriate medical monitoring for clinical studies
  • Ensure the study-related safety of the subjects in the clinical trials through appropriate medical monitoring of studies on a proactive and ongoing basis
  • Evaluate pharmacology, safety and efficacy data from ongoing and completed studies
  • Interface with clinicians/investigative sites for protocol-related issues, including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Perform review and clarification of trial-related Adverse Events (AEs)
  • Perform medical case review of Serious Adverse Events (SAEs) including review of case documentation, and patient narrative
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Be a 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 EMA filings and prepare relevant sections of the regulatory documents
 
qualifications:
  • MD or DO with experience of agency communication preferred
  • At least 3-5 Years of experience in clinical development or medical monitoring
  • Clinical practice including post-graduate direct patient care experience; Board certification or equivalent, neurology or psychiatry preferred
  • Ability and desire to work in a team-oriented environment and work effectively with cross functional teams
  • Excellent verbal, writing, presentation, and editing skills
  • Knowledge in FDA, EMA, PMDA and other regulatory requirements, GCP/ICH
 
skills: CRF, FDA, Clinical research, CRFs, GCP (Good Clinical Practice), SAE (Serious Adverse Event), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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