Executive - Clinical QC

Novumgen; Vadodara; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Novumgen seeks a Clinical QC professional with 5–6 years of experience to perform QC reviews of clinical study documents and ensure data integrity in accordance with approved protocols and regulatory requirements.

The role includes verifying source data, CRFs/eCRFs, and lab records, reviewing electronic systems and audit trails, and supporting CAPA and investigations as needed. Strong knowledge of ICH-GCP and regulatory guidelines is essential.

Qualifications

• Requires 5–6 years in monitoring clinical activities.
• Bachelor or higher degree in pharmacy or related field.
• Familiarity with ICH-GCP, regulatory requirements (NDCTR 2019) and SOPs.

Responsibilities

• Perform QC review of clinical study documents and records.
• Review records for ALCOA+ principles and data integrity.
• Verify studies follow approved protocol, amendments, SOPs, and regulatory requirements.
• Conduct QC checks of critical activities and records (ICF, screening, dosing, sampling, safety).
• Verify consistency between source documents, CRFs/eCRFs, and lab records.
• Review electronic systems and audit trails.
• Identify missing or unreliable data and escalate appropriately.
• Document discrepancies and QC findings per procedures.
• Communicate critical quality issues promptly to relevant personnel.
• Track responses, CAPA, and resolution of findings; verify effectiveness.
• Support risk-based quality oversight focusing on critical processes.
• Review QC metrics, trends, and quality indicators periodically.
• Support investigations of discrepancies and data integrity concerns.
• Maintain awareness of ICH-GCP and CDSCO requirements; regulatory updates.

Skills

QC review

ALCOA+ data integrity

Regulatory compliance

Risk-based oversight

CAPA management

Education

B.Pharm.

M.Pharm.

MSc or equivalent

Tools

eCRF systems

Quality management software

Job description

Job Description

Position Title- Clinical QC

Department- Clinical Affairs

Experience Requirement: 5-6 years of experience in monitoring clinical activities.

Qualification Requirement: B.Pharm., M.Pharm., MSc. or an equivalent qualification in a relevant scientific discipline.

Profile Requirements:

• 1. Perform QC review of clinical study documents and records as per approved protocol and procedures.
• 2. Review clinical study records for ALCOA+ principles, data integrity, and proper documentation practices.
• 3. Verify that study activities are performed in accordance with the approved protocol, amendments, SOPs, and applicable regulatory requirements.
• 4. Conduct QC checks of critical study activities and records, including Informed Consent, Participant screening and eligibility records, Dosing, Sample Collection and Processing, Safety and Adverse Event, Investigational Product related documents, Protocol deviations etc.
• 5. Verify consistency between source documents, CRFs/eCRFs, laboratory records, and other relevant study records.
• 6. Review electronic systems and applicable audit trails.
• 7. Identify missing, inconsistent, erroneous, or potentially unreliable data and ensure appropriate escalation and resolution.
• 8. Document identified discrepancies, observations, and QC findings in accordance with established procedures.
• 9. Communicate critical or significant quality issues to the appropriate personnel without undue delay.
• 10. Track responses, corrections, CAPA, and resolution of identified findings. Verify implementation and effectiveness of corrective actions.
• 11. Support risk-based quality oversight by focusing QC activities on critical processes and data.
• 12. Participate in periodic review of QC metrics, trends, and quality indicators
• 13. Support investigation of discrepancies, deviations, data integrity concerns, and other quality events.
• 14. Maintain awareness of applicable requirements, including ICH-GCP, NDCTR 2019, applicable CDSCO requirements, and other relevant regulations/guidelines.
• 15. Support implementation of changes arising from regulatory updates, revised SOPs, and quality-system improvements.
• 16. Support QA during internal audits, sponsor audits, regulatory inspections, and vendor audits, as required.
• 17. Participate in training on SOPs, protocols, systems, and applicable regulatory requirements.
• 18. Identify opportunities for process improvement and prevention of recurring quality issues.