Data Manager

📋 Description

• Lead Data management activities and ensure study deliverables meet timelines and quality standards.
• Review of Clinical research documents (e.g. protocols, Case Report Forms).
• Create and review electronic Case Report Form (eCRF) specifications.
• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF
• Develop edit rules/checks, query logic and query messages.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.

🎯 Requirements

• Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing
• Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
• Working knowledge of Clinical research and clinical trial process and related regulatory
• Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave
• Perform duties in compliance with SOPs, GCP and ICH guidelines.
• Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.