Associate - Trial Capabilities

JOB DESCRIPTION

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 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.

Purpose :

The Trial Capabilities Associate (TCA) provides clinical trial capabilities in support of clinical development. The TCA 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 TCA may be assigned responsibilities within any trial capability, including obtaining clinical trial authorizations and ethics approvals, execution of the budget and contract, and activities related to investigator grants execution. The TCA will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed / appropriate for the local geography and / or to cover regional differences.

Primary Responsibilities :

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Trial Responsibilities :

• Initiate investigator activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for an investigator’s ERB and Competent Authority (CA) (where applicable), communicate and negotiate budgets with investigator personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure investigator (and / or delegate) compliance to required training, track and ensure investigator (and / or delegate) access to required clinical systems and supplies, and effectively drive timelines aligned with company priorities
• Communicate directly with investigators (and / or delegates) to enable start-up and maintain an active collaboration during maintenance and close-out
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents / systems
• Leverage previous investigator / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / investigator performance
• Understand and comply with procurement, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities
• Coordinate investigator grant responsibilities such as purchase order creation, management, and P2P processes related to payment execution and / or reporting. Lead collection efforts for advanced and overpayments and ensure financial reconciliation required for studies for CRF payments and invoiced deliverables are effectively completed.

Minimum Qualification Requirements :

Additional Requirements / Preferences :

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$65,250 - $148,500

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and / or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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