Brief Position Description:
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.
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 other study data documents)



received and entered; 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 required.
• Mentor junior CDA staff as required.
• Represent Data Management Team on all CDA related matters, both internally and externally e.g. Investigator meetings, audits etc.
• Support CDM with CDM role activities where appropriate.
• Can act as internal DM Lead on studies, reporting to CDM/SCDM on a study level.
• Liaison with ex

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