Clinical Data Specialist

Overview

Clinical Data Specialist role supporting data management, clinical programming and Electronic Data Capture (EDC) systems in the pharma or medtech industry.

What you'll do

• Collaborate with cross-functional teams to adapt and implement technical solutions for data management, executing the technical setup of clinical programming and EDC systems.
• Ensure adherence to data management standards and procedures by confirming compliance with regulatory requirements and organizational protocols, working under general supervision.
• Develop and maintain documentation for data management processes and procedures, drafting SOPs and work instructions as needed.
• Ensure efficient execution of data processing tasks according to established protocols, providing inputs and suggestions to ensure data accuracy and integrity.
• Support the preparation and presentation of clinical data for analysis and reporting, producing summaries, tables and graphs as directed by project requirements.
• Troubleshoot data-related issues and escalate technical challenges to senior team members or relevant stakeholders, ensuring timely resolution.
• Provide guidance to colleagues on data management tasks, sharing knowledge and best practices to facilitate skill development and learning.
• Collaborate with biostatistics and statistical programming teams to understand data analysis requirements and facilitate data transfer and integration processes.
• Evaluate data quality and completeness to assess suitability for analysis and reporting, identifying discrepancies and anomalies for further investigation or correction.

What you'll need

• Bachelor's Degree or Vocational Education in Medical or Lifesciences, or equivalent.
• 5-8 years of experience with a Bachelor's degree.
• Experience in Data Management in the Pharma industry or Medtech industry.

Nice to have

• CCDM or relevant certification.
• Bachelor's Degree.
• 5-8 years of experience.
• Medidata database programmer experience.
• Experience in Medidata Rave and Greenlight Guru.
• Experience in Pharma or Medtech industry.

Details

• Location: Bangalore.
• Office-based role: in-person at least 3 days per week.