Senior Associate, Trial Capabilities

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 66,000 - 154,000; Full time

Benefits offered by this job

401(k)

Pension plan

Vacation benefits

Job summary

Lilly in Indianapolis, IN seeks a Trial Capabilities Senior Associate to provide clinical trial capabilities in support of clinical development. You will ensure investigator sites meet requirements to enroll participants and support site maintenance and close-out.

Responsibilities span initiating investigator activities, handling regulatory documents, negotiating budgets and contracts, maintaining Trial Master Files, and ensuring training and compliance across global sites.

Qualifications

• Bachelor’s degree preferably in a scientific or health related field.
• Two years clinical research experience or relevant experience preferred.
• Candidates must be legally authorized to work in the United States on a full-time basis.

Responsibilities

• Initiate investigator activities and submit regulatory documents.
• Customize and negotiate informed consent documents; liaise with ERB/CA where applicable.
• Negotiate and obtain fully-executed contracts; manage investigator budgets.
• Track training and access to clinical systems and supplies for investigators.
• Populate Trial Master Files and related systems; ensure compliance and readiness.

Skills

Lean Six Sigma

Regulatory knowledge

Budget negotiations

Project management

Communication skills

Education

Bachelor’s degree in science/health field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose: The Trial Capabilities Senior 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

Bachelor’s degree preferably in a scientific or health related field.

Two years clinical research experience or relevant experience preferred. Qualified candidates must be legally authorized to be employed in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, L-1.

Additional Requirements/Preferences

• Lean/Six Sigma background
• 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
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skillsSelf-management and organizational skills

Language Capabilities

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

EEO/DEI Statement

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Compensation & Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is $66,000 - $154,000. 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.

Company Culture

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. 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! #WeAreLilly