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Stryker, a global leader in medical technologies, is hiring a Specialist (In-House Monitor) in Bengaluru. This opportunity is ideal for professionals with experience in clinical operations, eTMF management, centralized monitoring, and regulatory compliance within clinical studies—especially in the medical device industry.
If you are looking for a clinical research job in Bangalore, in-house monitor jobs, or centralized monitoring roles in pharma/biotech, this position offers long-term growth in a global organization.
🔍 Job Overview
- Position: Specialist (In-House Monitor)
- Company: Stryker
- Location: Bengaluru, Karnataka
- Experience: 3–5 years
- Employment Type: Full Time, Permanent
- Department: Research & Development / Clinical Operations
🧾 Key Responsibilities
- Perform essential document collection, review, indexing, quality control, and filing in Electronic Trial Master File (eTMF)
- Ensure compliance with ICH-GCP, ISO 14155, local regulatory requirements, and SOPs
- Serve as Independent Essential Document Reviewer / second reviewer when required
- Track studies in CTMS or sponsor systems to maintain accurate and complete files
- Support centralized monitoring activities including risk analysis and Key Risk Indicators (KRIs)
- Assist Lead Monitor and Clinical Study Managers in managing investigational sites and timelines
- Follow up with sites for invoices and ensure timely investigator payments
- Support investigational product accountability, CRF retrieval, and query resolution
- Contribute to development of procedures, dashboards, and metrics
🎓 Qualifications & Skills
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
- GCP / ISO 14155 certification or Postgraduate degree in Clinical Research preferred
Experience
- 3–5 years in clinical studies or in-house monitoring
- Strong understanding of TMF reference models (DIA/CDISC)
- Experience with Medidata eTMF or Veeva Vault preferred
Technical Skills
- Document management & Good Documentation Practices (GDocP)
- Internal auditing / site auditing (added advantage)
- Microsoft Office, Smartsheet, Power BI
Soft Skills
- Excellent written and spoken English communication
- Strong organizational and analytical skills
💼 Benefits of Working at Stryker
- Work with a global medical device leader
- Career growth in clinical operations & centralized monitoring
- Exposure to international clinical trials
- Competitive compensation and benefits
📌 How to Apply
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