Job at Novotech for Life Science Graduates – Apply Online
Join Novotech as a Clinical Data Associate II, where you’ll find the ideal environment for Clinical and Life Science graduates to thrive. In this role, you’ll leverage your academic background to make a meaningful impact in the dynamic field of clinical data management. Our team at Novotech welcomes your expertise and offers opportunities for career growth and development. So, apply online for the job at Novotech for LifeScience Graduates
Job Title: Clinical Data Associate II
Location: Bangalore
Company: Novotech
Minimum Qualification: Graduates in Clinical or Life Science related field
Experience: 2-4 years of experience in research, pharmaceutical industry or related field
Job Description:
- Supports the day-to-day operations of the data management projects.
- Providing in-house data entry support to projects.
- Administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements, and Novotech/Client SOPs.
Responsibilities of Life Science and Clinical Graduates at Novotech:
- 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.
Possible Interview Questions and Answers:
- Can you explain your experience with clinical data management and relevant software tools?
Answer: “In my previous role at [Previous Company], I was responsible for clinical data collection, cleaning, and validation using tools such as Medidata Rave and Oracle Clinical. I also ensured data integrity and compliance with industry standards like CDISC. This experience has given me a strong foundation in clinical data management.”
2.How do you ensure data quality and accuracy in clinical trials?
Answer: “I maintain data quality by implementing rigorous validation checks, resolving discrepancies promptly, and conducting regular data review meetings with the team. I also adhere to data standards and follow best practices outlined in SOPs to ensure accuracy.”
3.Can you describe your familiarity with regulatory guidelines and standards relevant to clinical data management?
Answer: “I am well-versed in regulatory guidelines, such as ICH GCP, 21 CFR Part 11, and CDISC standards. I have consistently applied these guidelines to maintain data integrity, patient safety, and compliance in all my previous projects.”
4.How do you handle unexpected data discrepancies or anomalies during a clinical trial?
Answer: “When I encounter data discrepancies, I investigate their root causes, collaborate with the appropriate team members, and document the resolution process thoroughly. This ensures that we maintain data quality and compliance.”
5.Can you describe your experience with electronic data capture (EDC) systems and their advantages in clinical data management?
Answer: “I have extensive experience with EDC systems like Medidata Rave and understand their advantages, including real-time data access, reduced data entry errors, and improved data monitoring capabilities. EDC systems streamline data collection and enhance data quality.”
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