- Communication skills (Written/Oral).
- Attention to details.
- Teamwork and collaboration.
- Ability to work independently.
- BA/BE Process clinical domain knowledge required.
- Computer skills (MS-Word & Excel).
- Positive analytical skills and proactive thinking.
Detailed Responsibilities:
- Conduct of Clinical BA/BE study audits.
- Review of PK & Stat data, CDISC data.
- Review of draft Protocols, ICD, CRF and Clinical Study report.
- Conduct of System and Vendor audits.
- Review of clinical draft SOPs.
- Facilitating in support for client/regulatory audits.
- Review of client audit Reponses.
- Provide inputs for client RFI.
- Identify the gaps and contribute for QMS improvement.
📌 QA Auditor - BA/BE (India)
🏢 Advity Research
📍 India
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