Brief Position Description:
The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-II (CDP-II) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP).
Responsibilities :
• The CDP-II shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP-II shall ensure quality standards per SOPs and ICH-GCP.
• Participates in project team meetings as required.
• The CDP-II shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards.
• Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards.




• Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices.
• Experience in developing, validating and maintaining clinical trials built in different EDC applications.
• Ability to learn recent process, programming languages and adapt with new technologies.
• Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.
• To have the technical knowledge and provide guidance on providing interfaces or data exchanges between the clinical database and other database, programming or reporting systems.
• Support in the validation of electronic systems, software and programs implemented in accordance with current regulatory requirements.
• Support on project meetings and telephone conferences where required. The CDP shall support the Project Lead on a project on tasks as needed.

Requir

📌 Clinical Data Programmer II (Bengaluru)
🏢 Novotech Global
📍 Bengaluru