Clinical Research Specialist

2 weeks ago

Petaling Jaya, Malaysia Eli 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 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 Clinical Research Specialist provides clinical trial capabilities in support of clinical development. The Specialist 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 Specialist is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, records management and site training. The Specialist will ensure inspection readiness at all time following GCP and any local/regional requirements.

**Responsibilities**:

- 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
- 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
- Populate internal clinical trial systems ( e.g. IMPACT, Vault Clinical, Shared Investigator Platform ) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Ensure complete, accurate and readily available Trial Master F ile

**Minimum Qualification Requirements**:

- Bachelor’s degree preferably in a scientific or health related field
- Four (4) 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)

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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