Sr. Clinical Data Manager Job at cGxPServe, Dallas, TX

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  • cGxPServe
  • Dallas, TX

Job Description

Responsibilities:
  • 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 tools.
Requirements:
  • BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
  • 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 pre-emptively 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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