Are you passionate about advancing healthcare through meticulous clinical data management and regulatory submissions? Freyr Solutions, a leading name in life sciences, is hiring a Clinical Data Management Specialist in Hyderabad to support groundbreaking clinical trials. Join a dynamic team dedicated to ensuring compliance and accelerating the delivery of life-saving medicines. If you thrive in a fast-paced environment and have expertise in regulatory submissions, this role is your chance to make a global impact!
Responsibilities
- Oversee end-to-end clinical data management processes, ensuring data integrity and compliance with regulatory standards.
- Prepare and review clinical trial data for regulatory submissions to agencies like DCGI, FDA, and EMA.
- Collaborate with cross-functional teams, including biostatisticians and clinical research associates, to ensure data accuracy.
- Implement data quality checks and resolve discrepancies in clinical trial datasets.
- Maintain compliance with ICH-GCP guidelines and CDISC standards.
- Support audits and inspections by regulatory authorities.
- Contribute to process improvements in clinical data management workflows.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- 2+ years of experience in clinical data management or regulatory submissions.
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical) and CDISC standards.
- Strong understanding of clinical trial processes and regulatory requirements (DCGI, FDA, EMA).
- Excellent analytical skills and attention to detail.
- Familiarity with GxP compliance and data privacy regulations.
- Effective communication and teamwork skills.
Benefits
- Competitive salary range of INR 6,00,000–10,00,000 per annum, based on experience.
- Comprehensive health insurance and wellness programs.
- Opportunities for professional growth in a global life sciences organization.
- Collaborative and inclusive work culture.
- Flexible work arrangements, including hybrid options in Hyderabad.
How to Apply
Ready to contribute to life-changing clinical trials? Send your CV/Resume to palak.pandya@freyrsolutions.com with the subject line “Clinical Data Management Specialist Application – [Your Name].
