Creates and maintains database infrastructure for the collection of clinical data according to PRA and/or client Standard Operating Procedures (SOPs). This includes the design, implementation and validation of databases, edit checks, import/export of external data, and creation of SDTM deliverables.
- Perform billable work in accordance with PRA’s policies and standard operating procedures (SOPs) to provide consistent high quality deliverables
- Familiarity with the study protocol
- Define databases and data entry screens for clinical trials
- Program edit checks for clinical databases based on the Data Validation Plan
- Import non-case report form (CRF) data into the clinical database as described in the Data Transfer Agreement and/or SOPs
- Reconcile non-CRF data with data from the CRF
- Create appropriate sections in the Data Transfer Agreements
- Review and approve database definitions for clinical databases and edit checks
- May create annotated CRFs
- Assists in the locking of study databases (import external data, extraction of final data from database)
- Assist in the training of junior Database Programmers
- May attend sponsor meetings, as required
- May assist in communication with vendors as it relates to data imports
- Bachelor’s degree in a quantitative or scientific field, or its international equivalent from an accredited institution.
- Minimum of two years industry related database programming experience required.
- Minimum of two years experience with Oracle, SQL, PL/SQL, and/or SAS required.
- Experience with clinical trials or the pharmaceutical industry.
- Knowledge of data structure standards (CDASH, SDTM).
- Demonstrated ability to succesfully interact with internal clients and related department/functions.
- Experience with programming in SAS and working with EXACT.
- Experience in Oracle Clinical and/or Medidata Rave.
- Experience with industry standard clinical data management systems preferred.
- Experience with PL/SQL development tool preferred.
- Experience as primary representative of clinical data management project team preferred.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.