Lilly Senior Clinical Research Associate - Trial Capabilities 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 35,000 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 Senior Associate provides clinical trial capabilities in support of clinical development. The Sr Associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The Sr Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, records management and site training. The Sr Associate will ensure inspection readiness at all time following GCP and any local/regional requirements.
Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority.
Communicate with sites, Lilly functions, clinical research organization to enable start-up and maintain an active collaboration with sites during maintenance and close-out
Act as subject matter expert on Trial Capabilities topics and provide oversight, coaching and technical support to Associates in managing high priority and complex clinical trials.
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
Coordinate the management and delivery of clinical trial material to ensure support of site initiation
Strategic use of internal clinical trial systems (e.g. IMPACT, Vault Clinical, TrialForce) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
Ensure complete, accurate and readily available Trial Master File
Minimum Qualification Requirements
Bachelor’s degree preferably in a scientific or health related field
Three (3) years clinical research experience or relevant experience preferred
Understanding of the overall clinical development paradigm and the importance of efficient site activation
Applied knowledge of project management processes and skills
Appreciation of / experience in compliance-driven environment
Effective communication, negotiation, and problem-solving skills
Self-management and organizational skills
Language capabilities – English (read, write, conversation)
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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!