Sr. Clinical Data Manager
- The Clinical Data Manager is responsible for timely and high quality data management deliverables supporting the client's portfolio. They will also establish assets and study level strategies in addition to conducting oversight using, predictive data monitoring practices from database activation through database release and submission. The Sr. Clinical Data Manager will contribute influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
- Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
- Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
- Strong knowledge of clinical study reporting requirements including SAS programming.
- Experience with all phases of development and at least 2 therapeutic areas.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience.
- Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
- Access to transportation to attend various meetings held in proximity to the client's offices.
- Able to fly to various meetings at investigator, vendor or regulatory agency sites.
- Some international travel may be required.