Trial Capabilities Assistant-10

2 months ago

Petaling Jaya, Malaysia Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Trial Capabilities Assistant (TCA) role provides technical support to clinical trial capabilities team in support of clinical development.
The TCA is responsible for activities related to study start-up (SSU) and investigator sites readiness for patient enrolment, maintenance and close out.

**Responsibilities**:

- Track and ensure site compliance to effectively drive clinical trial timelines aligned with company priorities
- Manage investigator site account requests to enable sites access to clinical trial systems and tools
- Track, support and communicate investigator site compliance to training requirements
- Accurate and complete data entry of clinical trial information into various clinical trial systems (e.g. Vault Clinical, eTMF) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File (TMF).
- Complete TMF quality review activities at defined study milestones. Identify, reconcile, communicate and ensure resolution of TMF completeness and quality issues.
- Ensure appropriate archiving of documents to meet Lilly record retention polices and regulatory requirements.
- Identify, communicate, and resolve issues in supporting study start-up, maintenance and close-out.

**Minimum Qualification Requirements**
- A diploma/degree or equivalent preferably in a scientific or health related field
- Clinical research experience or relevant experience preferred
- Applied knowledge of project management processes and skills
- Appreciation of/experience in compliance-driven environment
- Ability to learn and comply with regulatory requirements and internal policies.
- Effective communication, teamwork and problem-solving skills; good attention to details and accuracy; self-management and organizational skills
- Excellent computer skills
- Language capabilities - English (read, write, conversation)

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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