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Site Activation and Management Professional

2 weeks ago

Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full time
About Us
Eli Lilly and Company is committed to making life better for people around the world by discovering and delivering life-changing medicines. We strive to create a culture of excellence, innovation, and inclusivity, where our employees can grow and thrive. As a Senior Associate - Trial Capabilities, you will play a critical role in enabling clinical trials and advancing our mission.

Job Summary
We are seeking a highly motivated and detail-oriented professional to join our team as a Senior Associate - Trial Capabilities. In this role, you will provide critical support for clinical trial capabilities, ensuring that investigator sites are properly set up and maintained to enroll study participants efficiently. You will work closely with internal teams and external partners to drive timely activation, maintenance, and close-out of clinical trials. Your success in this role will be measured by your ability to identify and resolve issues promptly, escalate concerns to management and quality teams when necessary, and contribute to the development of Trial Master Files and libraries for future reference.

Key Responsibilities
  • Develop and execute strategies to initiate and manage investigator sites, including collection and submission of regulatory documents, negotiation of informed consent documents, and coordination with ethics review boards and competent authorities.
  • Cultivate strong relationships with internal teams and external partners to drive collaborative efforts during trial activation, maintenance, and close-out phases.
  • Provide expert guidance on country-specific regulatory and data privacy requirements to ensure compliance and seamless integration into submission documents and systems.
  • Collaborate with cross-functional teams to identify and address issues promptly, escalating concerns to management and quality teams when necessary.
  • Develop and maintain accurate records of trial and site performance using internal systems.

Requirements
To succeed in this role, you should possess a bachelor's degree in a scientific or health-related field, along with relevant clinical research experience. You must also demonstrate strong project management skills, effective communication and negotiation abilities, and a keen eye for detail.