Key Responsibilities :

- Design, develop, configure, and maintain clinical study databases using Medidata Rave EDC.

- Develop CRFs (Case Report Forms), edit checks, custom functions, derivations, and validation rules based on study protocols.

- Configure study metadata, forms, folders, matrices, dictionaries, and workflows within the Rave environment.

- Perform database builds, user acceptance testing (UAT), deployment, and post-production support.

- Develop and maintain custom functions using C# and Medidata Rave Custom Function programming.

- Create and validate data import/export processes and external data integrations.

- Support database migrations, amendments, mid-study updates, and version management.

- Collaborate with Clinical Data Management, Biostatistics, Clinical Operations, Medical Writing, and Programming teams to gather study requirements.

- Troubleshoot database issues, edit check failures, and system defects while ensuring timely resolution.

- Prepare technical documentation, validation documents, database specifications, and programming guidelines.

- Ensure compliance with CDISC, GCP, FDA, ICH, and 21 CFR Part 11 regulations.

- Participate in database review meetings and provide technical recommendations for study optimization.

- Support audit and inspection readiness by maintaining accurate programming and validation documentation.

Required Technical Skills :

- Strong hands-on experience with Medidata Rave EDC.

- Expertise in :

1. Rave Architect

2. Rave EDC Study Build

3. Edit Check Programming

4. Custom Function Development

5. C# Programming

6. Medidata Designer

7. Rave Web Services

8. Rave Configuration

- Knowledge of clinical trial workflows and electronic data capture systems.

- Experience with study amendments, migration, and database lock activities.

- Familiarity with CDISC standards including SDTM and CDASH.

- Understanding of clinical data management processes and validation methodologies.

- Knowledge of SQL for data validation and reporting.

- Experience working with clinical coding dictionaries such as MedDRA and WHO Drug is preferred.

Preferred Skills :

- Experience supporting Phase I-IV clinical trials.

- Exposure to Medidata Balance, RTSM, or eCOA integrations.

- Knowledge of Clinical Data Management Systems (CDMS).

- Understanding of GxP, GAMP, and regulatory compliance standards.

- Experience with Agile project methodologies.

- Medidata Rave Certification is an added advantage.

Desired Candidate Profile :

- 4-9 years of experience in Clinical Data Management or Medidata Rave Programming.

- Strong understanding of clinical trial protocols and study design.

- Excellent analytical and problem-solving skills.

- Strong verbal and written communication skills.

- Ability to work effectively with global cross-functional teams.

- Detail-oriented with a focus on quality and regulatory compliance.

- Ability to manage multiple clinical studies and deliver within project timelines.