Job Title : Clinical Data Manager

Location : Bangalore (On-site/Hybrid)

Experience : 37 Years

About the Role :

We are seeking a detail-oriented and proactive Clinical Data Manager to join our Clinical Operations team. In this role, you will lead end-to-end clinical data management activities across observational, prospective, and retrospective studies, ensuring the delivery of high-quality, regulatory-compliant clinical data. You will collaborate closely with Clinical Operations, Biostatistics, Regulatory, Product, and Engineering teams to support FDA-regulated software-based healthcare solutions.

Key Responsibilities :

- Lead end-to-end clinical data management activities from study start-up through database lock.

- Design, build, configure, and maintain clinical databases using Medidata Rave or a comparable EDC platform.

- Develop eCRFs, data dictionaries, database specifications, validation plans, and Data Management Plans (DMPs).

- Configure study visits, forms, user roles, workflows, and edit checks within the EDC system.

- Perform database validation, User Acceptance Testing (UAT), issue resolution, and production releases.

- Manage data cleaning, query resolution, reconciliation, and quality control activities.

- Support bulk data uploads and large-scale data ingestion for real-world and retrospective datasets.

- Collaborate with Biostatistics and Regulatory teams on interim and final database locks, SDTM reviews, and regulatory submissions.

- Ensure compliance with ICH-GCP, 21 CFR Part 11, company SOPs, and applicable regulatory requirements.

- Maintain audit trails, inspection readiness, and complete study documentation.

- Coordinate with CROs, vendors, and study teams to ensure timely project delivery.

- Train study teams on EDC systems, data entry standards, and best practices.

- Contribute to process improvements, SOP development, and enhancement of clinical data management capabilities.

Required Qualifications :

- Bachelor's degree in Life Sciences, Health Informatics, Pharmacy, Biotechnology, or a related field.

- 4+ years of experience in Clinical Data Management within a CRO, pharmaceutical, biotechnology, medical device, or healthcare organization.

- Hands-on experience with Medidata Rave or similar Electronic Data Capture (EDC) platforms.

- Experience designing eCRFs, database build/configuration, edit checks, and database validation.

- Strong understanding of clinical trial processes, ICH-GCP, 21 CFR Part 11, and clinical data management principles.

- Familiarity with CDISC/SDTM standards.

- Experience managing clinical databases through database lock.

- Advanced Microsoft Excel skills; knowledge of SQL or data validation tools is an added advantage.

- Excellent analytical, communication, and stakeholder management skills.

- Ability to manage multiple studies in a fast-paced environment.

Preferred Qualifications :

- Experience working with Real-World Data (RWD) and retrospective datasets.

- Exposure to Medical Device, Diagnostics, or Software as a Medical Device (SaMD) clinical studies.

- Experience supporting FDA-regulated clinical programs.

- Prior experience collaborating with global teams and external vendors/CROs.

Why Join Us :

- Work on cutting-edge AI-powered healthcare technologies with real-world clinical impact.

- Collaborate with multidisciplinary global teams across Clinical, Regulatory, Engineering, and Product functions.

- Opportunity to contribute to FDA-regulated digital health innovations and scientific advancements.

- Dynamic, collaborative, and growth-oriented work environment.