Bachelors degree or equivalent in a scientific or health care field is required. Masters degree is preferred.
o 8+ years of related clinical research experience with a minimum of 3-5 years of clinical trial management experience in a Pharmaceutical/Biotech organization
o Minimum of 3-5 years of CRO/vendor management experience
o Familiar with advanced concepts of clinical research and demonstrated ability to work effectively in a team/matrix environment
o Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
o Familiarity with advanced concepts of clinical research; understanding of the pharmaceutical industry practices and standards for new drug development; Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, US Food and Drug Administration (FDA), FDA CFR, European and International guidelines, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive.
o Clinical Research Associate (CCRA) Certification and Project Management for Professionals (PMP) Certification preferred.
o Able to provide clinical operations expertise to clinical development in a specified product area or project
