What Youll Do: Assist with the development and modification of department SOPs and work instructions Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians Develop study bids and changes in scope for Biostatistics
What Youll Do: Handle incoming and outgoing calls by using a Clinical research database to recruit, screen, determine eligibility, schedule, and follow-up with potential study subjects and responds to inquiries relating to advertising and referrals to
Job Purpose The Medical Director will be responsible for growing and leading a therapeutic portfolio through their medical and clinical development expertise and by providing medical and safety monitoring of awarded clinical trials. The Medical Director
ESSENTIAL FUNCTIONS Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment Conduct protocol risk reviews and
Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation