Responsibilities:
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team. Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data-related issues and discrepancies. Generate and review data listings, summaries and reports for data review. Serve as a primary or backup resource for issues about data management. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute to the development and validation of data management software.
Requirements:
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience. 5-7 years of data management experience in the pharmaceutical or biotechnology industries. Strong expertise in project/program management including stakeholder management. Knowledge of industry standards (CDISC, SDTM, CDASH). In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11. Proven ability to preemptively identify data and system issues and mitigate risks to data quality. Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data. Experience in development and implementation of Clinical data management standards and procedures. Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
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