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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 purpose of the Clinical Trial Registry and Transparency (CTRT) Associate is to support the development and implementation of CTRT systems and processes, ensuring Global transparency regulations and requirements are described and implemented. The CTRT associate will collaborate with cross-functional, multidisciplinary teams across geographies and phases of drug development to ensure/coordinate the accurate and timely posting of applicable clinical trial protocol information and study results.

**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 Registry and/or Results Development

+ Collaborate cross functionally with applicable team members and departments (for example, statistics, medical, clinical trial managers, legal), to obtain information required for completion of trial registry and results entries.

+ Translate study designs and/or study results into the format required by Clinicaltrials.gov and Lilly Trials.

+ Ensure study information and data are presented in a clear, complete, accurate, and concise manner.

+ Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content as required based on internal/external input, and prepare final version.

+ Ensure and coordinate quality checks for accuracy.

+ Understand and adhere to the requirements for ClinicalTrials.gov as well as Lilly's requirements for study registration and results posting.

+ As needed, may build and manage relationships with vendors/alliance partners/acquired companies.

+ Serves as subject matter expert on CTRT requirements and provides education/training to business partners.

Project and Stakeholder Management

+ Lead the content creation process and apply effective project management skills to ensure timely completion of high-quality study registrations and/or results.

+ Build/communicate credible project timelines.

+ Anticipate and mitigate risks to delivery.

+ Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.

+ Effectively communicate project status to stakeholders.

+ Escalates issues in a timely and appropriate manner.

Knowledge and Skills Development

+ Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).

+ Exhibit flexibility in moving across study registrations and results, therapeutic areas, phases of development, and compounds, depending on project assignment.

+ Maintain and enhance knowledge of regulatory and Lilly guidelines

+ Share learning with colleagues and business partners.

Minimum Qualification Requirements:

+ Bachelor’s degree in scientific, health, communications, or technology related field

+ Or, Bachelor’s degree in any field with at least two years of clinical development experience.

+ Understanding of medical terminology and clinical studies.

+ Strong communication and interpersonal skills.

+ Demonstrated high-level end-user computer skills (MS office applications: Word, Excel, PowerPoint, etc.).

Other Information/Additional Preferences:

+ Experience with CTRT processes and databases, such as Vault Clinical and Clinicaltrials.gov.

+ Experience in biostatistics, medical/regulatory writing, or clinical development.

+ Verbal reasoning, attention to detail, critical thinking, and analytical ability.

+ Demonstrated project management and time management skills.

+ Ability to be flexible in varying environments and with multiple customer groups.

+ Able to work independently as well as part of a team: able to take initiative and responsibility, following through and completing assigned tasks.

+ Able to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.

+ Experience working within multiple functional areas across medical, regulatory and legal.

+ Strong interpersonal and negotiation skills - Ability to manage upwards.

+ Developed networks and proven ability to influence cross-functionally at all levels.

+ Ability to influence/lead others.

+ Ability to work well across cultures and time zones.

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 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

$63,000 - $140,800

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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