Clinical Data Manager / Programmer

August 26

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Syreon Corporation

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Transforming research in rare and complex diseases

Phase I-IV trials • Health Economics and Outcomes Research • Strategic Pricing and Value Dossier • Precision Medicine Trials • Pragmatic Trials

51 - 200

Description

• Design and validate clinical databases, including designing or testing logic checks • Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data • Process clinical data, including receipt, entry, verification, or filing of information • Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems • Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, CRFs and work flow processes • Monitor work productivity or quality to ensure compliance with standard operation procedures • Prepare appropriate formatting to data sets as requested • Design forms for receiving, processing, or tracking data • Prepare data analysis listings and activity, performance, or progress reports • Analyze clinical data using appropriate statistical tools • Write work instruction manuals, data capture guidelines, or standard operation procedures • Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation • Track the flow of work forms, including in-house data flow or electronic forms transfer

Requirements

• Bachelor’s degree in life sciences • At least 3 years industry experience within the health sciences/CRO or pharmaceutical industry • Good knowledge in medical terminology and Electronic Data Capture (EDC) process • Excellent knowledge of ICH/GCP, FDA, and HPB regulations • Programming skills or experience with SAS or R is an asset • Strong attention to details and thorough in achieving quality work to meet company standards • Strong interpersonal and leadership skills, including adaptability, flexibility, and professional integrity