Clinical Data Manager

Overview

Remote
Depends on Experience
Full Time

Skills

Clinical data management
SAS
SQL
Problem solving

Job Details

Job Title: Clinical Data Manager
Location: Remote
Duration: Long Term
Client: Ascendion/J&J
Candidate need to work in PST Timings!!!
Key Responsibilities
  • Data Management Planning: Develop and implement comprehensive data management plans (DMPs) for clinical studies.
  • Database Design & Maintenance: Create, test, and maintain clinical trial databases using industry-standard tools (e.g., Medidata Rave, Oracle Clinical).
  • Data Quality Assurance: Perform data validation and ensure data accuracy through query management and discrepancy resolution.
  • Regulatory Compliance: Ensure compliance with Good Clinical Practice (Google Cloud Platform), FDA, EMA, and other regulatory standards.
  • Collaboration: Coordinate with cross-functional teams, including clinical research associates, biostatisticians, and regulatory specialists.
  • Documentation & Reporting: Prepare data management documentation and support audits and inspections as needed.
  • Technology Utilization: Leverage electronic data capture (EDC) systems to streamline data collection and reporting.
Qualifications
  • Education: Bachelor s degree in Life Sciences, Computer Science, or a related field (Master s preferred).
  • Experience:
    • 3+ years of experience in clinical data management, preferably in CROs, pharma, or biotech.
    • Proficiency in EDC systems (e.g., Medidata, REDCap, Oracle Clinical).
  • Technical Skills:
    • Strong knowledge of SQL, SAS, or similar data analysis tools.
    • Familiarity with CDISC standards (e.g., SDTM, ADaM).
  • Soft Skills:
    • Excellent organizational and communication skills.
    • Strong attention to detail and problem-solving abilities.
Preferred Qualifications
  • Certification in clinical data management (e.g., CCDM).
  • Experience with regulatory submissions and audit readiness.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.