Trial Capabilities

2 weeks ago

Gurugram Haryana, India HCAH Full time

Clinical Trial Responsibilities
- Assist investigator site activation activities, including compilation and submission/notification of regulatory documents.
- Assisting Trial Capabilities Associate on study document management & tracking for IRB/IEC submissions throughout the study.
- Track site compliance to required training to effectively drive timelines aligned with company priorities.
- Communicate directly with sites to enable start-up, as required, and maintain an active collaboration with sites during maintenance and close-out.
- Coordinate translation process for clinical trial documents.
- Manage/coordinate clinical trial system account request for investigator sites, as applicable.
- Identify, communicate, and resolve issues.
- Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems including maintaining systems and local tracking tools to allow tracking, performance metrics reporting and to meet Lilly and regulatory compliance requirements.
- Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements.
- Support inspection readiness through a complete, accurate and readily available Trial Master File including performing quality review periodically on documents related to Trial Capabilities.
- Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)

Qualification: B- pharma, M- pharma with 2 years of experience.

**Job Types**: Full-time, Permanent

**Salary**: ₹40,000.00 - ₹45,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

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