Clinical Data Manager II

Position Overview

We are seeking a Clinical Data Manager II to support clinical data collection, validation, database development, and compliance activities across clinical trials. This role will leverage clinical data management expertise and technical automation skills to improve data quality and operational efficiency.

Key Responsibilities

  • Manage clinical data collection, cleaning, validation, and query resolution activities.
  • Support EDC database development, testing, and data validation processes.
  • Develop automation scripts and tools to streamline data management workflows.
  • Support data standardization and reporting activities.
  • Ensure compliance with GCP, regulatory requirements, and SOPs.
  • Maintain study documentation and support audit readiness.
  • Collaborate with cross-functional teams to support study execution and data quality.

Required Qualifications

  • Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
  • 2+ years of clinical data management experience within clinical trials.
  • Experience with EDC platforms such as Medidata Rave, Veeva Vault CDMS, REDCap, or Oracle InForm.
  • Proficiency in Python and experience with data automation, validation, or reporting tools.
  • Knowledge of GCP, 21 CFR Part 11, and clinical trial data management practices.
  • Strong analytical, problem-solving, and communication skills.

Preferred Qualifications

  • Master's degree in a related field.
  • Experience with SQL, R, or SAS.
  • Experience with CDISC standards, including SDTM and CDASH.
  • Experience supporting regulatory inspections or quality audits.

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].