eClinical Solutions empowers life sciences organizations to accelerate clinical trials through advanced data services and the elluminate Clinical Data Cloud. Their integrated platform and analytics enable smarter, faster decision-making in digital trials.
Job Title: QC Specialist (eTMF Document Specialist)
Location: Bangalore, Karnataka
Industry: Pharmaceutical/Biotechnology
Experience: 2-3 years
Detailed Job Description
Key Responsibilities:
✔ Perform QC review of Trial Master File (TMF) documents for accuracy, completeness, and compliance with ICH-GCP, FDA, EMA regulations.
✔ Verify document filing, indexing, and metadata accuracy in eTMF systems (Veeva, Trial Interactive).
✔ Identify discrepancies, missing documents, and track remediation.
✔ Collaborate with study teams, CROs, and regulatory affairs to resolve issues.
✔ Support audit/inspection readiness and contribute to TMF health reports (KPIs).
✔ Train and mentor junior QC specialists.
✔ Ensure compliance with eClinical Solutions SOPs and industry standards.
Professional Skills & Experience:
- 2-3 years in pharma/biotech or related field.
- Strong knowledge of ICH-GCP, DIA TMF Reference Model, 21 CFR Part 11.
- Experience with eTMF systems (Veeva, Trial Interactive).
- Detail-oriented, multitasking, strong communication skills.
Eligibility & Qualifications:
- Bachelor’s degree (preferably in Computer Science, Life Sciences, or Health-related fields).
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Excellent English communication (written & verbal).
Benefits & Perks
✅ Competitive salary & growth opportunities
✅ Work with cutting-edge eTMF & clinical data systems
✅ Collaborative & innovative work environment
✅ Training & mentorship programs
