Sr. Clinical Data Manager

Karwell Technologies

Waukegan, ILContractorPosted May 6, 2026

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Qualifications

  • •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 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
  • •6 more items(s)

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 tools
  • •11 more items(s)
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