Clin Database Prog/Oracle Clinical (DG)
Job Location: Northern, NJ
Work Type: Onsite
Clinical Database Programmer/Oracle Clinical (Contract, long term, W2 or Corp to Corp, unlimited renewals)
Pharmaceutical/Biotechnology, Northern NJ
Rate is open, must have current
Recent pharmaceutical or biotechnology experience.
Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical or CentralDesigner in accordance with company standards. 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 Rave, 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 standards. Validate peer programming. Participate in and lead team meetings when appropriate. Act as primary CRO contact, when necessary, to ensure that standards are implemented in all studies. Provide technical expertise and support to Data Management team. Control access to database and perform snapshots, database lock and freeze activities. Make data, including interim data, available to company personnel and regulatory agencies when required. Perform post processing of data extracts in accordance with standards to be delivered to Biostatistics. Routinely interface with cross-functional team members. Influences other functions and represents as DBO technical expertise. Internal team leader who decides best course of action. Coach and advise junior programmers to identify problems and solutions. Manage outside CROs and consultants. Review clinical programming activities and costs in contracts. Assess CRO data management systems for regulatory compliance. Interact with CROs in the design and development of databases that are compatible with company needs. Monitor progress of clinical programming activities in CROs. Participate in regular team meetings and provide input when appropriate. Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock. Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities. Direct responsibility for supervising and training junior clinical programmers in the performance of their duties. Managing project priorities and timelines.
BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years of experience. Work experience in Medical Affair and Oncology Studies are preferred. Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems). Experience managing clinical programmers. Participation in at least one NDA is preferred. 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. Medical or mathematics/computer science background a plus. Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation. Knowledge of SQL and SAS programming. Computer skills: detailed knowledge of clinical database design (Rave, Oracle Clinical or Inform), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite. Knowledge of clinical trial design and basic statistics (a plus).
Please contact Darren Gutowski at firstname.lastname@example.org
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