Job Description: Department: Clinical Affairs

Role: Clinical Data Management

Experience Required: 4–7 Years

Corporate Office, Ahmedabad

A key objective of this position is to primary point of contact for EDC-related activities, responsible for overseeing the configuration, database design and user training of EDC systems. Creating and maintaining electronic case report forms (eCRFs) in alignment with clinical study protocols, ensuring accurate data collection, cleaning and reporting. The objective is to contribute to the productive execution of data management plans and the overall success of clinical trials.

Bachelor's degree in pharmacy or related field, with 4 to 7 years of experience in Clinical Data Management.

Detail-oriented skilled with comprehensive knowledge of EDC systems, database design and data management in clinical trials.

Prior experience in ensuring compliance with regulatory guidelines and optimizing data management processes is essential.

Create and maintain eCRFs in accordance with clinical study protocols, ensuring data accuracy and consistency.





Contribute to the development and execution of data management plans aligned with study protocols.

Oversee the setup and configuration of EDC systems, including designing eCRFs, edit checks, and data validation processes.

Manage data queries and discrepancies, collaborating with study sites for timely resolution.

Verify and validate clinical trial data for the database lock process, preparing documentation for regulatory submissions.

Identify prospects for process optimization, standardization and efficiency enhancement in data management practices.

Ensure compliance with regulatory guidelines (EU MDR, USFDA, ANVISA, MDR 2017, TGA) and data management best practices.

Archive clinical trial data as per relevant regulatory requirements.

Work closely with cross-functional teams to ensure seamless data flow and communication throughout the trial.

Comprehensive knowledge of EDC syste

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