Data Systems & Clinical Programming Specialist (Contractor)

The Data Systems & Clinical Programming Specialist (Contractor) will be responsible to support Data Management (DM) as part of the Clinical Programming function in a rapidly evolving environment, in accordance with industry standards. This role will support Data Systems and Clinical Programming activities and deliverables across programs as directed by the Director and Associate Director, DS&CP.

Essential Responsibilities:

• Support development and production operation activities within the Data Systems and Clinical Programming function
• Maintain Smartsheet trackers for report requests, Production reports, and other DS&CP operational documentation
• Participate in the development of report specifications for SAS Clinical Programming reports, and other custom reports/outputs as needed
• Review programmed reports/outputs for accuracy against requirements and provided specifications
• Provide/transfer source files for reports and dashboards and ensure automated transfers have completed successfully
• Transfer programmed reports/outputs to appropriate locations for cross-functional team use
• Support requests for new/updated Automated Transfer Service (ATS) vendors and jobs and investigate issues or trigger jobs manually as needed
• Provide user access for DM tools
• Support Alumis’ standard CRFs and standard edit checks initiatives
• Participate in EDC, IRT, and eCOA User Acceptance Testing (UAT)
• Ensure DS&CP study-specific documentation is in an inspection-ready
• Support DS&CP in cross-functional meetings, as applicable
• Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements
• Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data

Qualifications:

• 5+ years of relevant experience and has earned a BS or equivalent degree
• 2+ years of experience with clinical trials and data management
• Understanding of the programming development life cycle
• Knowledge and experience in EDC
• Experience with SAS, SQL, and/or other clinical programming tools
• Experience working and effectively communicating with global programming teams preferred
• Experience with CDISC standards (CDASH, SDTM) preferred
• Strong interpersonal, organizational, and communication (oral and written) skills
• Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
• Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude