Principal EDC Programmer
Program and test Electronic Data Capture (EDC) systems for conducting clinical trials. Coordinate tasks and resource allocation for projects under the supervision of the Manager of Project Programming. Develop training materials and assist with the development of programming work practices as needed.
ESSENTIAL JOB FUNCTIONS: DUTIES AND RESPONSIBILITIES:
• Work with the Manager of Project Programming to coordinate programming tasks and resources during the development of EDC systems.
• Serve as backup to the Manager of Project Programming as needed.
• Develop and deliver training courses for other Programmers and IQVIA Biotech staff.
• Assist with the development and maintenance of departmental and divisional work practices, SOPs and forms.
• Assist with budget review for new proposals and CCBs as assigned.
• Supervise other Programmers, ensuring that departmental, divisional, and corporate standards and practices are followed.
• Track new releases and versions of EDC software and communicate within IQVIA Biotech as needed.
• Evaluate new software and provide recommendation for adoption.
• Assist with the validation of new software and releases.
• Perform same duties as Senior EDC Programmer.
KNOWLEDGE, SKILLS AND ABILITIES:
• Knowledge of clinical research process and methodology.
• Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
• Ability to help supervise resources and plan long-range tasks for EDC development.
• Ability to conduct training sessions with existing training modules and update or create new training modules as needed.
• Ability to manage software releases and report software issues to EDC vendor.
• Ability to program electronic case report forms (eCRF’s) and edit checks within an EDC system.
• Ability to work creatively and independently to carry out assignments of a complex nature.
• Ability to communicate and work effectively and cooperatively with other professional staff members.
• Ability to learn new programming languages, technology, and tools that will facilitate the clinical trial process.
MINIMUM RECRUITMENT STANDARDS:
• BS in Computer Science or related field with a minimum of 5 years of work experience in programming; or Associate’s in Computer Science or related field with a minimum of 6 years of work experience in programming; or high school diploma (or equivalent) with 7 years of work experience in programming; or equivalent combination of experience and knowledge.
• Programming experience with one or more of the currently supported IQVIA Biotech EDC platforms.
• Excellent interpersonal and organizational skills required.
• Experience building studies using Medidata Rave EDC system is required.
• Experience programming custom function/set up RTSM for Rave Medidata system is a plus but, not required.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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