Contract Senior/Lead Clinical Data Manager Job at Hydrogen Group, San Mateo, CA

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  • Hydrogen Group
  • San Mateo, CA

Job Description

Responsibilities
  • Lead data management activities for in-house clinical trials, ensuring timely and accurate data collection, cleaning, and validation
  • Oversee and manage CROs handling outsourced clinical data activities, ensuring adherence to protocols, timelines and quality standards
  • Ensure compliance with GCP, regulatory guidelines (FDA, EMA, ICH), and internal SOPs
  • Design, implement, and maintain clinical trial databases (e.g., EDC systems)
  • Review data quality, identify issues, and lead troubleshooting efforts for data discrepancies
  • Collaborate with clinical, biostatistics, and regulatory teams to ensure smooth data flow and timely reporting
  • Provide training and mentorship to junior data management staff as needed

Qualifications

  • Bachelor's degree in Life Sciences or related field
  • 5-7 years of clinical data management experience, including both in-house studies and CRO oversight
  • Proficiency with EDC platforms and clinical data management systems
  • Strong knowledge of GCP, FDA regulations, and ICH guidelines
  • Excellent communication and organizational skills


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Job Tags

Contract work,

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