Clinical Data Manager Job at cGxPServe, Dallas, TX

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  • cGxPServe
  • Dallas, TX

Job Description

Responsibilities:
  • Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
  • Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
  • Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
  • Develop and oversee maintenance all data management documentation for all clinical studies.
  • Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
  • Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
  • Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
  • Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
  • Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
  • Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
  • Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
  • Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
  • Develop, implement, and continuously improve clinical data management processes and systems.
  • Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.
Requirements:
  • Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
  • Strong understanding of data structure and data systems.
  • Minimum of 5+ years of experience in clinical data management.
  • Proven experience managing data across multiple phases of clinical trials
  • Proficiency with EDC systems (e.g., Medidata Rave, Medio).
  • Strong understanding of CDISC standards (CDASH, SDTM, Adam) as well as WHO Drug and MedDRA coding.
  • Familiarity with data reporting tools is a plus.
  • Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards.
  • Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
  • Excellent communication, problem-solving, and decision-making skills.
  • Certified Clinical Data Manager (CCDM) or similar certification is preferred.

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