Responsibilities:

• Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).
• Support database setup activities including edit check specifications and user acceptance testing (UAT).
• Review incoming clinical data for completeness, consistency, and accuracy.
• Generate, track, and resolve data queries in collaboration with clinical sites.
• Maintain study documentation and data management files.
• Participate in cross-functional study team meetings and data review discussions.
• Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging).
• Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC).

Requirements:

• Bachelor’s degree in a life science, health science, pharmacy, public health, or related field.
• Strong attention to detail, organizational, and time management skills.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective written and verbal communication skills.
• Ability to learn and apply technical systems and software (EDC, CTMS, etc.).
• Familiarity with clinical trial processes and Good Clinical Practice (GCP).
• Experience with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio) a plus.

• Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).
• Support database setup activities including edit check specifications and user acceptance testing (UAT).
• Review incoming clinical data for completeness, consistency, and accuracy.
• Generate, track, and resolve data queries in collaboration with clinical sites.
• Maintain study documentation and data management files.
• Participate in cross-functional study team meetings and data review discussions.
• Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging).
• Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC)