Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
Attends and presents at investigator and sponsor meetings
Provides medical consultation to clients, investigators and project team members
Supports business development activities
Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports
Requirements
MD or equivalent required
Active medical licensure preferred but not required
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicant's training (comparable to 2 years)
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry;
Direct experience in safety/Pharmacovigilance (comparable to 2 years)
Knowledge of relevant safety databases (e.g. Medra)
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Benefits
competitive remuneration
annual incentive plan bonus
healthcare
a range of employee benefits
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