Jobs in Cambridge, MA

About the role

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. The purpose of this position is to provide therapeutic area/program data management expertise and leadership by: Defining the data capture and data management vendor strategies to meet the requirements of global development programs. Position may lead complex projects associated with various global alliances. Ensuring consistent program-level data collection, data cleaning and data management plan standards. Managing the collection, validation, coding and storage of clinical program data; enforcing standardization to maximize global data integration and inter-program efficiency.

What you'll bring

• BS/BA required preferably in a health-related, life science area and with a minimum of 7 years data management and/or drug development experience.
• Experience with all phases of development and at least 2 therapeutic areas.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience.
• Previous experience with EDC study conduct.
• Advanced knowledge of relational databases (e.g., Oracle-based systems) and experience using multiple clinical data management systems including EDC.
• Strong knowledge of clinical study reporting requirements including SAS programming.
• Advanced knowledge of office software (Microsoft Office).
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• 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.
• Prefer Certified Clinical Data Manager (CCDM), as administered by the Society for Clinical Data Management (or equivalent certification).