Clinical Data Manager Job at cGxPServe, Detroit, MI

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  • cGxPServe
  • Detroit, MI

Job Description

Responsibilities:
  • Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
  • Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
  • Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
  • Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
  • Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
  • Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
  • Perform quality control and audit activities to ensure data accuracy and compliance.
  • Support data reviews and provide metrics and status updates to project teams and leadership.
Requirements:
  • Bachelor's degree in Life Sciences, Computer Science, or a related field.
  • Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.
  • Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
  • Strong knowledge of CDISC standards, including SDTM and ADaM.
  • Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
  • Exceptional attention to detail and problem-solving skills.
  • Ability to work independently and communicate effectively with diverse stakeholders.

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