Clinical Data Associate Ii

3 weeks ago

Bengaluru, India Novotech Asia Full time

Brief Position Description:
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.

Minimum Qualifications & Experience:
Graduate in a clinical or life sciences related field. Relevant experience /qualifications in allied professions may also be considered. At least one to two years' experience working in research, pharmaceutical industry, or a related field.

**Responsibilities**:
Member of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate II 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 and assist 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 and assist CDM with data cleaning/validation and reconciliation of external data.
- Assist CDM to create reports, listings, and other output as required during 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.) and provide updates on study progress to CDM as required. Also, assist with agenda/minute writing for data management teams.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

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