Full Time

Specialist (In-House Monitor)

Stryker
Bangalore
Competitive Salary
Posted 07/02/2026

About the Role

Roles & Responsibilities
• Perform collection, review, indexing, quality control, and filing of essential documents in the Electronic Trial Master File (eTMF)
• Ensure eTMF completeness and compliance with ICH-GCP, ISO 14155, local regulations, and internal SOPs
• Act as Independent Essential Document Reviewer / second reviewer when required
• Track clinical studies in CTMS and sponsor systems to maintain accurate documentation
• Support centralized monitoring activities including risk analysis and Key Risk Indicators (KRIs)
• Assist Lead Monitors and Clinical Study Managers with site management and study timelines
• Follow up with investigational sites for invoices and ensure timely investigator payments
• Support investigational product accountability, CRF collection, and query resolution
• Contribute to development and improvement of procedures, dashboards, and study metrics

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline
• GCP / ISO 14155 certification or Postgraduate qualification in Clinical Research preferred

Experience
• 3–5 years of experience in clinical studies, in-house monitoring, or centralized monitoring
• Prior experience in medical device studies is an advantage

Skills
• Strong knowledge of ICH-GCP, ISO 14155, and regulatory requirements
• Hands-on experience with eTMF systems (Medidata eTMF or Veeva Vault preferred)
• Understanding of TMF Reference Models (DIA / CDISC)
• Good Documentation Practices (GDocP) knowledge
• Exposure to internal or site auditing is an added advantage
• Proficiency in MS Office, Smartsheet, Power BI
• Excellent communication, organizational, and analytical skills

About the Organization
Stryker is a global leader in medical technologies, dedicated to improving patient outcomes through innovative products and solutions. With a strong focus on quality, compliance, and clinical excellence, Stryker offers long-term career growth and exposure to global clinical research and medical device development.

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