Clinical Research • Clinical Trials • Phase I-II • Human Abuse Liability & Abuse Potential • Early Cardiac Safety & TQT
November 5
Clinical Research • Clinical Trials • Phase I-II • Human Abuse Liability & Abuse Potential • Early Cardiac Safety & TQT
• Responsible for developing high-quality programming that supports sponsors’ research programs. • Perform SDTM, ADaM, and TFL programming, QC review, and documentation of programs. • Understand regulatory agency standards and provide final deliverables accordingly. • Collaborate with Lead Biostatisticians to resolve study-related questions. • Perform peer review and ensure programming accurately reflects raw data. • Follow current SDTM standards and current ADaM Implementation Guides. • Lead studies from a programming perspective as assigned. • Monitor progress and quality of other programmers to meet expectations. • Review clinical database regarding data collection. • Create Biostatistics deliverables that follow the protocol and SAP. • Accurately import external data and provide findings for discrepancies. • Provide technical expertise and solutions to the team. • Mentor and train programmers and develop training materials.
• Bachelor's Degree in programming, health-related sciences, or relevant field • Excellent verbal and written communication skills. • Professional attitude and strong interpersonal skills. • Ability to work well with a multi-disciplinary team of professionals. • Client-focused approach to work. • Flexible attitude with respect to work assignments and new learning. • Ability to prioritize workload. • Superior attention to detail. • Understanding of clinical research and the relationship of Data Management in the clinical study process. • Strong technical aptitude and ability to adapt to multiple data management platforms. • Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to multiple information technology (IT) systems.
• Health/Dental/Vision Insurance Plans • RRSP with Employer Match • Paid Vacation and Holidays • Paid Sick and Bereavement Leave • Employee Assistance & Telehealth Programs • Training & Development Programs • Employee Referral Bonus Program • Annual Performance Reviews
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