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KNOWLEDGE AND SKILL REQUIREMENTS
Technical knowledges
? Programming skills by SAS
? Knowledge of industry standards and practices (e.g. CDISC/CDASH)
Problem solving & Decision making
? Anticipate complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.
? Ability to analyze issues (i.e. context, impact risk)
? Ability to make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
Oversight & Coordination
? Ability for performing quality controls and ensuring maintenance on databases
? Strong organizational skills and ability to handle multiple tasks, paying attention to details and defining priorities.
Act for change
? Be flexible to change, managing internal and external challenges & opportunities
? Readily adapt to new environment, jobs, technologies ,processes (e.g. new CDMS, tools, process of UNIFY) and outsourcing models (VSP, SSP….)
Collaboration and communication
? Excellent interpersonal and communication skills, with other departments and external partners.
? Sufficient competence in English to ensure DM programming activities across the global Trial Operation organization
KEY ACCOUNTABILITIES:
? Configure and execute existing tool and/or program to generate Patient Profiles for Data Validation & Medical Review;
? Develop ad hoc listings/summary tables/figures for data Validation/data review/medical review/ AE dedicated review / SAE manual reconciliation in various formats; distribute the report production to the customers following the process channel in place. It includes checks involving external data (i.e., cross-panel checks and internal/external data reconciliation)
? Prepare individual deviations listing: develop the corresponding program to facilitate the automatic deviations management.
? Apply mapping for external data according to internal standards and specification, and feedback the external data issue to the internal and external partner(i.e. CTOM/CEP DM and external vender)
? Liaise with Data Reporting Analyst(DRA) to continuously maintain and optimize the existing standard reporting tools, programs and report library.
? Develop new SAS tool/package to facilitate the programming for better quality and efficiency.
? Writing/ and manage the technical/and process supporting document at team level(i.e. reporting tool user guide, detailed specification, best practice, convention)
? Analysis the new requirement from customer and propose technical solution strategy.
? Feedback customers and management with regarding process improvement and solution optimization periodically
? Especially for studies fully outsourced to CROs:
? Run OpenCDISC/Pinnacle 21 and support CTOMs by identifying type of errors (data quality errors versus SDTM structure issues)
? Provide specific ad-hoc listing/dashboards for oversight
? Check that CDISC Controlled Terminology is correctly applied
? Check Laboratory Unit conversions
? Apply mapping for external data if applicable (e.g., pre-reconciliation)
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
At least bachelor degree in computer science, or relevant field
Experience:
Min 1/2 yr. SAS programming experience . Good programming skill required. Former pharmaceutical experience preferred.