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Associate Director, Medial Monitoringjob details:location:Princeton, NJ
salary:$180,000 - $200,000 per year
date posted:Thursday, January 21, 2021
experience:3 Years
job type:Permanent
industry:Professional, Scientific, and Technical Services
reference:34789
job descriptionAssociate Director, Medial Monitoringjob summary: IMMEDIATE NEED for an Associate Director/Director, Medial Monitoring in the Princeton, NJ area. Must be an MD or DO, be able to speak Mandarin, and have at least 3-5 years of experience in Medical Monitoring.location: Princeton, New Jerseyjob type: Permanentsalary: $180,000 - 200,000 per yearwork hours: 9 to 5education: Doctorateresponsibilities: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 RegulationsEqual 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.
