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 Database

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