Our client is an AI-driven healthcare technology company developing innovative solutions to transform cardiovascular care.

We are looking for an experienced Clinical Data Manager to join their Clinical Operations team and play a key role in managing high-quality clinical trial data for cutting-edge AI-based healthcare products.

Note : The ideal candidate should have hands-on database build experience, not just database usage.

Key Responsibilities :

- Manage end-to-end clinical data management activities across clinical studies.

- Design, build, and maintain clinical databases using EDC platforms such as Medidata Rave or similar.

- Develop eCRFs, data dictionaries, and data management documentation.

- Perform data validation, query management, and quality checks to ensure data accuracy and integrity.

- Support database lock activities, user acceptance testing (UAT), and data reconciliation.

- Collaborate with Clinical Operations, Biostatistics, Regulatory, Product, and Engineering teams.

- Ensure compliance with GCP, HIPAA, GDPR, and applicable regulatory standards.

- Support real-world data (RWD) management and large clinical datasets.

- Contribute to process improvements and best practices in Clinical Data Management.

Required Skills :

- 4- 6+ years of experience in Clinical Data Management.

- Hands-on experience with EDC systems (Medidata Rave or similar).

- Strong understanding of clinical trial processes and GCP guidelines.

- Experience with eCRF design, data validation, query management, and database lock activities.

- Familiarity with HIPAA, GDPR, and clinical data privacy requirements.

- Excellent communication, analytical, and stakeholder management skills.

Preferred Experience :

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

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

- Knowledge of CDISC/SDTM standards.

- Basic SQL or data extraction experience is an advantage.

Education :

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

Why Join?

- Work on cutting-edge AI solutions transforming cardiovascular healthcare.

- Collaborate with global clinical, regulatory, and engineering teams.

- Be part of a fast-growing HealthTech company focused on innovation and patient outcomes.

The Clinical Data Manager should be able to :

- Design the database for a clinical study

- Create electronic Case Report Forms (eCRFs)

- Configure study visits and workflows

- Define data validation rules (edit checks)

- Set user roles and permissions

- Perform User Acceptance Testing (UAT)

- Release the database for use in the clinical trial