Responsibilities

Member of the project team reporting to the Biometrics Project Manager on projects, the
Clinical Data Associate I is responsible for providing accurate data acquisition, data
validation and reconciliation to the clinical studies and shall ensure quality standards per
SOPs and ICH-GCP.
- Data entry of clinical trial data using Clinical Data Management software.
- Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
- Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
- Assist CDM with database testing and edit checks testing as appropriate.
- Assist CDM with data cleaning/validation and reconciliation of external data
- Develop and maintain good communications and working relationships with lead CDMs.
- Assist CDM to create reports, listings, and other output as required during the course of the project.
- May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.




- Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.
- Participation in project meetings as requested by CDM.
- Assist with agenda/minute writing for data management teams.
- Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
- Provide general admin support to Data Management according to the needs of the Clinical Data Manager.
- Active contribution to company process improvement initiatives as assigned.
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
- Participation in industry fora (conferences, qualified associations, etc) as a means of professional development as well as promotion of N

📌 Clinical Data Associate (India)
🏢 Novotech
📍 India