About the role:

Senior Clinical Data Associate -responsible for day-to-day data processing operations for data management projects, including CRF (or other study data document) tracking, entry, and filing. Provides administrative and project management support to CDMs for data management projects as required, including creation and maintenance of project files. Support and mentor junior staff members. Conducts all responsible activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Minimum Qualifications & Experience:
- Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.
- At least 2-4 years' experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role.

Responsibilities:

Member of the project team reporting to the Biometrics Project Manager on projects, the Senior Clinical Data Associate is responsible for independently providing accurate data acquisition, data validation,



reconciliation and mentoring the junior staff to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.
- Perform comprehensive data management tasks including data review, query management, external data reconciliation.
- Tracking of CRF pages (or otherstudy data documents) received andentered; tracking of data queries received; proactive metric reporting of CRF pages (or other study data documents) received and entered to study team members
- Prepare and validate database specification and edit checks specification procedures
- Accurate and timely filing of CRFs (or other study data documents), DCFs, or other
- DM related documents (eg. Data Management Plan, Self-Evident Corrections).
- Accurate and timely archiving of study DMF, CRF Files, and Data Query Master File.
- Perform user acceptance testing of Data Entry Screen and consistence checks of
- Clinical Study Databases as requi

📌 Senior Clinical Data Associate (India)
🏢 Novotech Global
📍 India