Skills and Education:
• BA/BS in relevant field. Years of experience may substitute for education.
• Years of experience: 5-10 years
• Effective organizational and communication skills
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
• Demonstrated project management, risk assessment and time management skills
• Previous relevant Electronic Data Capture (EDC) experience
• Detail oriented; performs quality and accurate work
• Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills
• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
• Thorough knowledge of FDA regulations, ICH GCP guidelines, Study Data Tabulation Model (SDTM), CDISC (Clinical Data Interchange Standards Consortium), database development, UAT, medical coding, the drug development process.
• Knowledge and understanding of DM Lifecycle associated with Phase 1 through Phase 3 studies, including pivotal, blinded, and randomized trials
• Prior experience writing specification documents and/or work instructions
• Previous vendor/CRO management
• Previous experience with Randomization and Trial Supply Management (RTSM)/Interactive Web Response System (IWRS) and electronic Patient Reported Outcomes (ePRO) systems preferred
• Database development experience preferred
Knowledge of python, R and SQL
• SAS programming experience preferred
• Oncology experience preferred
