The posting
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—but 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 skills
Self-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.
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).
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.
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