- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience
- Advanced knowledge of clinical database design is a must (RAVE, InForm, Oracle Clinical)
- Demonstrated proficiency in creating standard operational metadata, and CDASH compliant CRFs
In-depth understanding of CDASH and SDTM requirements
- Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
- Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
- Knowledge of SAS programming
Responsibilities will include, but are not limited to:
- Develop, program, test and maintain clinical trialdatabases and data entry screens using Oracle Clinical, Medidata Rave and InForm in accordance with Client standards.
- Develop standard CRF metadata per Client standards; contribute to the creation of CDASH compliant CRFs.
- Review computer validation/edit checks for in-house and outsourced studies.
- Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS.
- Develop, program, test and maintain data review listings in Oracle Clinical, InForm, JReview and/or SAS for data review purposes.
- Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Client standards.
- Participate in and lead team meetings when appropriate.
- Act as primary CRO contact as needed to ensure that Client standards are implemented in all studies.
- Provide technical expertise and support to data management and study teams.
- Control access to database and perform snapshots, database lock and freeze activities in accordance with Client SOPs.
- Make data, including interim data, available to company personnel and regulatory agencies when required.
- Perform post processing of data extracts in accordance with Client standards to be delivered to Biostatistics.
- Routinely interface with cross-functional team members.