What are the responsibilities and job description for the Contract Senior / Lead Clinical Data Manager position at Hydrogen Group?
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
