Job Description

• Develop and implement data management plans for clinical trials.
• Ensure data quality and integrity throughout the trial.
• Develop and maintain study-specific data management documents such as data management plans, annotated CRFs, and database specifications.
• Collaborate with cross-functional teams to identify project priorities and timelines.
• Manage data quality assurance procedures and perform quality control checks.
• Ensure adherence to regulatory compliance by following relevant guidelines and standard procedures.
• Contribute to the development of standard operating procedures (SOPs) and work instructions.
• Prepare and review database validation and user acceptance testing.
• Perform database lock activities, including data reconciliation and database closure.

• Bachelor's degree in a relevant field such as life sciences or a related discipline.
• Freshers in clinical data management of drug development programs.
• Familiarity with regulatory guidelines such as ICH/GCP and FDA regulations.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organization skills.
• Good interpersonal and communication skills to work effectively in a team environment.

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