Sr. EDC Programmer
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Clinical Operations . Bothell, Washington
The Senior EDC Programmer is responsible for the development of the Electronic Data Capture (EDC) system and other related departmental systems for the purpose of collecting and reporting clinical study data. The Sr. EDC Programmer has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement.
- With limited oversight, perform and/or lead EDC development activities including but not limited to electronic CRF design, visit schedule development, edit check programming, validation requirements, and post-production modifications
- Support and/or lead data reporting activities including gathering and compiling user requirements, development of report specifications and development of automated, standardized and ad hoc reports
- Support and/or lead EDC global library development
- Support and/or lead research, evaluation and development of departmental initiatives and new technologies/innovations to improve EDC Systems processes; represent the EDC Systems team through working groups (internal and external) and initiatives
- Minimum 8+ years of direct experience working in a biotech/pharmaceutical/medical environment.
- Previous clinical trial database design and EDC experience using Medidata products such as RAVE, a clinical data management systems software
- Previous report generation skills using reporting software required (ie. Business Objects , Spotfire, Microstrategy, Crystal Reports, or other reporting software tool)
- Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
- Must work successfully in both an independent and team environment, be self-motivated and able to multi-task effectively
- Requires strong and effective written and verbal communication skills
- BA/BS in relevant field strongly preferred
- Previous experience with other Medidata products such as Balance, Patient Cloud, Rave Web Services and Safety Gateway preferred
- Previous experience with C# and SQL Server databases
- Previous experience with IWRS systems
- Knowledge of data management processes and practices from study start-up through submission and regulatory requirements is also a plus