Novotech is currently hiring for the Clinical Data Associate II position in Bangalore. This role supports data management projects, focusing on tasks like data acquisition, validation, reconciliation, and working with Clinical Data Managers (CDMs) to ensure adherence to quality standards in clinical trials. Candidates should have at least 2 years of experience working in the Clinical/ Biotech research/pharmaceutical industry, with a background in B.Sc., M.Sc., B.Pharm, or M.Pharm or Lifesciences.
◆ Novotech is currently looking for a “Clinical Data Associate II” to join our amazing team.
Clinical Data Associate II
Location: Bangalore (Hybrid)
Desired:
*At least 2 years of experience working in the Clinical/ Biotech research/pharmaceutical industry.
*CDA II will provide data entry assistance, operational & administrative support to CDMs, in accordance with GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs for data management projects.
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 the 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.
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 good communications and working relationships with lead CDMs.
7. Assist CDM to create reports, listings, and other output as required during the course
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management.
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