Lilly Trial Capabilities Assistant in Petaling Jaya, Malaysia
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 39,000 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. The TCA will ensure inspection readiness through a complete, accurate and readily available Trial Master File.
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. IMPACT, Vault Clinical, TrialForce) 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)
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!