Company Description Archimedis Digital is a global professional IT services company dedicated to building digital products and solutions exclusively for Life Sciences organizations. The company partners with clients to design and execute growth strategies across the digital life cycle, from concept to deployment. By combining deep Life Sciences domain knowledge with strong technology expertise, Archimedis Digital addresses complex cross-functional business challenges. Its offerings focus on simplifying digital transformation and helping clients achieve measurable business outcomes. Team members collaborate closely with global stakeholders and work at the intersection of healthcare, data, and technology.
Role Overview:
The Clinical Data Manager collaborates closely with cross-functional clinical teams and plays a pivotal role in clinical database development, maintenance, and data validation activities. This role involves leading and supporting the preparation of Data Mapping Specifications, designing and implementing edit checks, supporting User Acceptance Testing (UAT), and ensuring alignment with study protocols, regulatory requirements, and industry standards. The individual is expected to demonstrate strong analytical capabilities, attention to detail, and operational excellence while maintaining the highest standards of data quality, integrity, and compliance throughout the clinical trial lifecycle.
Responsibilities:
- Review protocol, CRF annotations, and data standards requirements and create and maintain Data Mapping Specifications (DMS) for clinical studies
- Map source data fields from EDC/eCRF systems to target datasets and variables
- Ensure compliance with CDISC standards such as SDTM and ADaM and validate mapping logic, derivations, and data transformations
- Review protocol, eCRF specifications, edit check specifications, and study requirements to prepare comprehensive edit check test cases
- Design, develop, and execute test cases for configured, custom, conditional, and dynamic edit checks in EDC systems
- Gather, analyse, document, and translate business requirements into functional solutions by interacting with users and stakeholders
- Validate edit check logic, query generation, derivations, and system behaviour against study requirements.
- Should understand and can discuss the application and implications of Post Production changes to process and relation to requirements
- Acting as a client liaison and representative communicating client feedback to appropriate representatives; acting to resolve outstanding issues on behalf of client in a timely manner
- Deliver studies according to client standards with a zero-defect rate
- Should support configuration and quality check with project teams to ensure solution will meet the business objectives of the requirements
- Manage project communications, track deliverables, identify risks, document project status, and support issue resolution activities
Experience:
- Familiarity with data management software and databases
- Knowledge on Edit check specification and Listings, edit check test cases and UAT
- Understanding of relevant regulations and guidelines (e.g. FDA, GCP)
- Knowledge of CDISC standards including SDTM, CDASH, and ADaM
- Ability to understand business processes and translate them into system configurations
- Excellent documentation and presentation skills
- Team collaboration and project coordination skills
- Ability to manage multiple tasks simultaneously
- Able to meet deadlines in a high-pressure environment
Preferred Skills:
- Experience with Medidata Rave EDC or Veeva Vault
- Exposure to or interest in learning clinical programming languages such as PL/SQL, SAS, C#, R, VB
- Sound knowledge on CDISC, STDM and ADaM standards
- Good understanding of clinical trial domain & overall EDC study setup & reporting process
Job Location: Guindy, Chennai
Salary: Commensurate with current experience
