Job Description

• 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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