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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Contract work,