Data Manager

About the role

ClinSoft LLC is seeking an experienced Data Manager to oversee the quality, accuracy, and integrity of clinical trial data throughout the study lifecycle. The role involves close collaboration with cross‑functional project teams and hands‑on work with electronic data capture (EDC) systems.

Key responsibilities

• Participate in the preparation and review of clinical research documentation such as protocols, CRFs, DMPs, and DVPs.
• Support database setup, programming activities, and CRF/eCRF design in partnership with statistical programmers and biometrics teams.
• Perform UAT, edit‑check testing, data entry testing, manual data reviews, discrepancy management, and query resolution.
• Provide EDC and process training to CRAs and site personnel, and ensure data quality before database lock.
• Monitor project progress, prepare status reports, and attend project and client meetings.

Required profile

• University degree in Data Science, Data Management, Computer Science, Economics or related field; PhD preferred.
• 3‑5 years of experience in clinical data management with strong knowledge of pharmaceutical development and regulatory requirements (FDA, EMA).
• GCP certification preferred and ability to work independently and within cross‑functional teams.

Required skills

• Experience with EDC systems and electronic CRF/eCRF design.
• Proficiency in SDTM annotation and data validation processes.
• Hands‑on experience with UAT testing and manual data review.