Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

The Senior CDM Programmer II provides technical leadership in clinical data management activities,
including database development, edit check programming, data validation, and reporting. This role
serves as a subject matter expert within a multi-disciplinary project team, ensuring deliverables are
completed on time, within scope, and in compliance with applicable standards and regulations. The
position also supports process improvement initiatives and contributes to the development of tools
and standards that enhance operational efficiency.

What You'll Do:

• Design, build, test, and maintain clinical study databases and edit checks.
• Configure and develop clinical studies in Medidata Rave, including eCRF design and
  deployments.
• Develop, test, and validate Rave Custom Functions using C#.
• Configure and manage the Rave Lab Module, including lab data imports and reconciliation.
• Define and import data into EDC systems.
• Develop and test listings and reports to support data review.
• Create automation tools and scripts using Python for data validation and reporting.
• Troubleshoot system issues and collaborate with cross-functional teams for resolution.
• Provide technical leadership and mentor junior programmers.
• Participate in process improvements, bid defenses, and SOP updates as needed.

Education & Experience Requirements:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification
• At least 5 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
  Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

• Strong experience with Medidata Rave (study build, edit checks, validation, deployment).

• Advanced experience developing Rave Custom Functions.

• Experience with Rave Lab Module and external lab data integration.

• Strong proficiency in C# programming language.

• Proficiency in Python for automation and data processing.

• Good understanding of AI-powered tools such as Gene.AI, ChatGPT, and similar generative AI
  platforms for productivity, automation, and process optimization.

• Experience with relational database systems (RDBMS).

• Proficiency with SAS, SQL, Crystal Reports, Spot Fire, and JReview.

• Strong understanding of GCP and clinical data management processes.

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

• Ability to manage multiple priorities in a fast-paced environment.

Working Conditions and Environment:

• The standard working hours are from 1:00 PM to 10:00 PM IST.
• Employees have the flexibility to choose between office, remote, or hybrid work options.

Why Join Us?

Join us in our mission to make the world healthier, cleaner, and safer by successfully implementing your expertise in data management. Apply today and become part of our ambitious team at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.).

Apply today to help us deliver tomorrow’s breakthroughs.