Clinical Database Programmer

4 weeks ago

Bengaluru, Karnataka, India Ascendion Full time

We're Hiring : Clinical Data Programmers (EDC/Rave)

Locations : Bangalore, Hyderabad, Mumbai, Pune, Delhi

Experience Required : 5-10 Years

Join our dynamic and growing team to contribute to impactful clinical trials that make a real difference in global healthcare outcomes.

Key Responsibilities :

- Design and develop eCRF layouts and build corresponding databases using Medidata Rave or other Electronic Data Capture (EDC) systems.

- Interpret clinical trial protocols to configure system settings and ensure alignment with study requirements.

- Implement protocol-driven logic, dynamic rules, and edit checks in the EDC system as per sponsor specifications.

- Develop and maintain Data Validation Specifications (DVS) and collaborate with cross-functional teams for validation processes.

- Build, test, and maintain standard and complex edit checks using Custom Functions in C# for Rave or equivalent functionality in other EDC platforms.

- Perform system configuration and user role setup in line with project needs.

- Ensure compliance with regulatory guidelines and Good Clinical Data Management Practices (GCDMP).

- Troubleshoot system issues, provide technical support, and perform quality control of EDC builds.

Qualifications :

- Bachelors degree in Life Sciences, Computer Science, Engineering, or a related field.

- 312 years of hands-on experience in clinical data programming with EDC systems, preferably Medidata Rave.

- Strong understanding of clinical trial processes and data management requirements.

- Proficiency in C# for custom functions (specific to Rave) or similar programming languages.

- Familiarity with GCP, GCDMP, and FDA regulations is a plus.

- Strong analytical, problem-solving, and communication skills.

(ref:hirist.tech)

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