Clinical Data Management Specialist at Biotech Healthcare, Ahmedabad
A rare chance has emerged for an experienced Clinical Data Management Specialist at Biotech Healthcare in Ahmedabad. The organization seeks a specialist with 4–8 years of experience in EDC and clinical data management to contribute to their clinical affairs team.
About Biotech Healthcare
Biotech Healthcare is a leading organization in the healthcare sector, specializing in innovative solutions and services. With a commitment to quality and excellence, the company operates in various fields, including clinical data management, to enhance the efficiency and effectiveness of clinical trials. Biotech Healthcare is dedicated to promoting diversity and ensuring equal opportunities for all individuals.
Location: Ahmedabad, Gujarat, India (Corporate Office)
Qualification: Bachelor’s in pharmacy or related field; EDC / clinical data management experience
Experience: 4–8 years
Employment: Full-time
Salary: Not disclosed
Clinical Data Management Specialist Job Description
Department: Clinical Affairs
Job Title: Sr. Executive / Asst. Manager
Role: Clinical Data Management
Experience Required: 4–8 Years
Job Location: Corporate Office, Ahmedabad
The primary objective of this position is to serve as the main point of contact for EDC-related activities. The specialist will oversee the configuration, database design, and user training of EDC systems, while also creating and maintaining electronic case report forms (eCRFs) in alignment with clinical study protocols to ensure accurate data collection, cleaning, and reporting.
Key Responsibilities
- Serve as the primary point of contact for EDC-related activities, demonstrating in-depth knowledge of EDC systems.
- 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 opportunities for process optimization, standardization, and efficiency enhancement in data management practices.
- Ensure compliance with regulatory guidelines and data management best practices.
Clinical Data Management Specialist Eligibility Criteria
- Bachelor’s degree in pharmacy or related field.
- 4 to 8 years of experience in Clinical Data Management.
- Detail-oriented professional with comprehensive knowledge of EDC systems, database design, and data management in clinical trials.
- Strong analytical and problem-solving skills.
- Effective communication and the ability to collaborate with cross-functional teams.
- Prior experience in ensuring compliance with regulatory guidelines.
How to Apply
Interested candidates can apply through the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Conclusion
This opportunity at Biotech Healthcare is ideal for qualified candidates looking to advance their careers in clinical data management. Interested individuals are encouraged to apply at the earliest to be part of a dynamic team dedicated to improving clinical trials and data management processes.
