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.

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

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 

Path/Level:  B1

The annual base salary for this position in country = United States of America ranges from: $33,750.00 - $80,000.00 USD

The job profiles on this job requisition are: Administration Services-Administrative-Multiple Function-B1-Admin-non AA, Administration Services-Administrative-Multiple Function-B2-Admin-non AA, Administration Services-Administrative-Multiple Function-B3-Admin-non AA

Note:  Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities.  Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting.  For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.

To understand a U.S. role’s salary range, employees should visit the U.S. LillyNow Total Base Pay page or contact HR Solutions. For roles located in Puerto Rico and outside the United States, employees should contact local HR or HR Solutions.

Organization Overview: The Trial Capabilities Specialist role provides technical support to the clinical trial capabilities team in support of clinical development.  The specialist is responsible for activities related to investigator readiness, maintenance and close out.  The specialist will ensure inspection readiness through a complete, accurate and readily available Trial Master File.  Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.    

Responsibilities:

Clinical Trial Responsibilities

• Initiate investigator activities, including collection and submission of regulatory documents. Track and ensure site compliance to 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

• Support TPO and investigator payments as appropriate

• Manage investigator (and/or delegate) account requests

• Invoice query resolutions

• Identify, communicate, and resolve issues Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.

• Ensure appropriate archiving of documents to meet Lilly record retention policies and regulatory requirements.

• Ensure inspection readiness through a complete, accurate and readily available Trial Master File

• Anticipate and monitor dynamically changing priorities

Minimum Qualification Requirements:

• A degree or equivalent preferably in a scientific or health related field,

• Two years clinical research experience or relevant experience preferred

• Applied knowledge of project management processes and skills

• Appreciation of / experience in compliance-driven environment

• Ability to learn and comply with regulatory requirements and internal policies.

• Effective communication, team work and problem solving skills

• Very good attention to details and accuracy

• Self-management and organizational skills

• Excellent computer skills

Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

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Lilly is proud to offer market-competitive employee benefits designed to empower you to live your best life.  Employees may elect medical, prescription drug, dental and/or vision coverage for you and your family in one of two health plan options, enjoy best-in-class mental health support, and concierge services for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation. We also support well-being with a fitness membership, health coaching, and wellness activities at no additional cost. Our retirement benefits are designed to help our employees feel secure in their financial future by including a defined benefit pension, a 401(k) match, and retiree medical coverage. We provide life and disability insurance for peace of mind and protection for you and your loved ones and paid time-off benefits to support you in life’s moments that matter including personal illness, caregiver, bereavement, and other family needs, in addition to annual paid vacation and holidays.  Lilly reserves the right to terminate or modify companyprovided benefits at any time in its discretion. The company compensation structures are aligned to the location of hire. The United States pay range and benefits offering do not apply to any location outside of the United States.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

#WeAreLilly