Supports the day-to-day operations of the data management projects, providing
in-house data entry support to projects and administrative support to CDMs,
according to GCDMP guidelines, local regulatory requirements and Novotech/Client
SOPs.
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.
1. Data entry of clinical trial data using Clinical Data Management software.
2. Assistance in review of data queries to be raised with sponsor
companies/monitoring staff.
3. Tracking of CRF pages received and entered, tracking of data queries sent
received and entered.
4. Assist CDM with database testing and edit checks testing as appropriate.
5. Assist CDM with data cleaning/validation and reconciliation of external
data
6. Develop and maintain valuable communications and working relationships with
lead CDMs.
7.
Assist CDM to create reports, listings, and other output as required during
the course of the project.
8. May coordinate activities related to coding and electronic data transfers,
and address resulting discrepancies.
9. 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.
10. Participation in project meetings as requested by CDM.
11. Assist with agenda/minute writing for data management teams.
12. Adherence to company Quality Policy and procedures as applicable to
carrying out job responsibilities.
13. Provide general admin support to Data Management according to the needs of
the Clinical Data Manager.
14. Active contribution to company process improvement initiatives as assigned.
15. Understand the responsibilities of Novotech as a service provider
📌 Clinical Data Associate (Bengaluru)
🏢 Novotech Global
📍 Bengaluru
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