Job Description
The purpose of this role is to provide clinical trial capabilities in support of clinical development.
The successful candidate will be accountable for ensuring that investigator sites meet requirements to support ongoing activities during site maintenance and close-out.
This includes obtaining clinical trial authorizations and ethical approvals for study changes and activities related to records management.
Additionally, the Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Primary Responsibilities:
* Leverage trial prioritization to manage all site maintenance requests to drive timelines aligned with company priorities
* Communicate directly with sites to maintain an active collaboration with sites during maintenance and close-out
* Manage any site level changes (change of Principal Investigator, Sub-Investigator and/or site location change)
* Anticipate and monitor dynamically changing priorities. Facilitate Site Level Informed Consent Form updates resulting from amendment/addenda, Investigator Brochure update, etc.
* Facilitate approval of additional patient-facing materials throughout the trial (site-specific recruitment material, patient- facing retention material, patient reimbursement, etc.)
* Complete site close-out verification activities
* Maintain an active collaboration with sites during maintenance and close-out
* Address requests related to the Clinical Study Report
* Maintain eTMF inspection-ready
* Identify, communicate, and resolve issues; collaborate with peers and cross-functional partners, as needed, to ensure effective site management
* Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
* Provide feedback and shared learning for continuous improvement
Minimum Qualification Requirements:
* Bachelor's degree preferably in a scientific or health related field
* Understanding of the overall clinical development paradigm
* Appreciation of / experience in compliance-driven environment
* Effective communication, negotiation, and problem-solving skills
Benefits:
Lilly offers a comprehensive benefits package that includes competitive pay, flexible working arrangements, opportunities for professional growth and development, and a range of wellness programs.
Our employees also have access to a range of benefits including employee assistance programs, mental health resources, and financial well-being support.
In addition, Lilly is committed to creating a diverse and inclusive workplace where everyone feels valued and respected.
Others:
At Lilly, we strive to create a workplace that is inclusive and supportive of all our employees.
Whether you're looking for a challenging and rewarding career opportunity or just starting out, we encourage you to explore our job openings and apply today!