Associate - Clinical Trials - Clinical Data

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 put people first and strive to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our worlds greatest health challenges.

Please note, this is a hybrid position 3 days onsite / 2 days remote

Purpose

This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs.

Responsibilities

Portfolio Strategy, Planning and Delivery

Define Lilly business requirements for the study / program for vendors to deliver

Ensure that data management timeline and results are delivered to scope, cost, and time objectives

Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities from study set up through trial execution through dataset delivery

Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)

Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis

Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)

Define and approve data quality and submission outputs and results

Project Management

Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives

Specifies the data collection tools and technology platforms for the trial / program

Drive standards decisions, implementation and compliance for the study / program

Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios

Facilitate / assimilate integration of disparate data sources into datasets for decision making

Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate

Effectively apply knowledge of applicable internal, external and regulatory requirements / expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables

Communication

Act as primary communication point for all data management activities related to a clinical study.

Report out status of data management milestones and data quality.

Partner with external data vendors : understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.

Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions.

Partner with cross-functional team members to ensure trial success through robust oversight / review.

Process Improvement

Continually seek and implement means of improving processes to reduce cycle time and decrease work effort

Represent data sciences processes in multi-functional initiatives.

Actively engage in shared learning across the Data and Analytics organization.

Work with partners to increase vendor / partner efficiencies

Minimum Qualifications

Masters degree in a scientific field such as Informatics / Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences (or Bachelors degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)

Other Information / Preferences

Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities

Demonstrated ability to effectively partner / influence a remote team and drive a technical project to deliver results

Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles

Demonstrated ability to lead development of creative data solutions to address clinical development challenges

Passionate about improving technological solutions using new technologies

Society of Clinical Data Management certification

Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, R and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS.

Experience with the following :

Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions

Utilization of clinical / drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical)

Strong therapeutic / scientific knowledge in the field of research

Knowledge of medical terminology

Domestic and International travel may be required

Ability to balance multiple activities, prioritize and manage ambiguity

Demonstrated exemplary teamwork / interpersonal skills

Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

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. 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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates 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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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