Job Title: Senior Quality Assurance Manager – Clinical Trials

Company: ClinFocus

Location: Remote (India)

Job Type: Full-time

Department: Quality Assurance / Regulatory Compliance

About ClinFocus

ClinFocus is a data-first, biometrics-focused Contract Research Organization (CRO) supporting modern clinical development with precision, speed, and regulatory rigor. We specialize in clinical data management, biostatistics, statistical programming, and AI-enabled analytics across interventional trials, Early Access Programs, registries, and Real-World Evidence studies. As a Medidata-accredited partner, we prioritize data integrity and compliance from protocol design through database lock.

Role Summary

We are seeking a Senior Quality Assurance Manager to lead and mature our GCP quality management system across clinical data and biometrics operations. You will own audit and inspection readiness, drive CQMS improvements, and act as the quality partner to data management, biostatistics, and programming teams. This is a remote role open to candidates across India.

Key Responsibilities

- Own and maintain the Clinical Quality Management System (CQMS), including SOPs, work instructions, and quality documentation aligned to ICH-GCP (E6 R2/R3) and applicable regulations.
- Plan, conduct, and report internal, vendor, and process audits; track CAPAs to closure and verify effectiveness.
- Lead sponsor and regulatory inspection readiness and support hosting of audits/inspections.
- Provide GCP and data-integrity (ALCOA+) oversight for data management, biostatistics, and statistical programming deliverables.
- Oversee computer system validation (CSV)



and compliance of clinical systems (e.g., EDC/Medidata Rave) with 21 CFR Part 11 / Annex 11.
- Manage deviations, quality events, root-cause analysis, and risk assessments.
- Deliver GCP and SOP training; build a culture of quality across project teams.
- Support proposals and client audits as the quality subject-matter expert.
- Track quality metrics and report to senior management.

Required Qualifications

- Bachelor's or Master's degree in life sciences, pharmacy, biotechnology, or a related field.
- 5+ years of progressive experience in clinical QA/GCP quality within a CRO, pharma, or biotech, including demonstrated audit leadership.
- Working knowledge of ICH-GCP, 21 CFR Part 11, EU Annex 11, and global regulatory requirements (FDA, EMA, CDSCO).
- Experience auditing clinical data management and/or biometrics processes.
- Strong CAPA, root-cause analysis, and risk-management skills.
- Excellent written and verbal English; able to work across time zones with a US-based team.

Preferred

- Experience with Medidata Rave or comparable EDC platforms.
- Exposure to RWE, registries, or Early Access Programs.
- Lead Auditor certification (e.g., ISO, GCP) or equivalent.

What We Offer

- Fully remote work from anywhere in India.
- Exposure to global, data-driven clinical programs.
- A cooperative, quality-first culture with room to shape the QMS.

How to Apply: Apply directly through Indeed with your updated resume.

ClinFocus is an equal opportunity employer.

Pay: ₹567,411.02 - ₹1,848,176.45 per year

Experience:

- Clinical research: 3 years (Required)
- Quality assurance: 3 years (Preferred)

Work Location: Remote

📌 Senior Quality Assurance Manager (India)
🏢 Clinfocus
📍 India