Skip to main content
Search Jobs

Associate Director Clinical Data Management

New York, New York

Apply NowApply Later
Req ID R-25381 Title Associate Director Clinical Data Management City New York State / Province New York Country United States Region Research

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 35,000 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.

Organization Overview: About Prevail Therapeutics

Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is focused on developing novel gene therapies for Parkinson’s disease and other genetically defined neurodegenerative diseases. Prevail is based in New York city at the Alexandria Center for Life Sciences.

Position Summary

We are seeking an experienced and highly motivated Associate Director- Clinical Data Management to manage and provide oversight of all data management (DM) activities in our studies. This position supports our clinical programs by contributing to the collection, cleaning, and reporting of our clinical trial data.

Responsibilities:

  • Oversight, management, and collaboration with project teams on all DM related aspects of assigned programs and/or projects. Assures overall quality and efficiency.
  • Management and oversight of Contract Research Organization (CRO) DM activities, including managing timelines and budgets.
  • Working knowledge of DM software and platforms (e.g. Oracle Inform, Medidata Rave) and eTMF (Veeva)
  • Oversight, development and execution for DM activities including data cleaning and validation plans, database specifications, electronic edit checks, UAT, cleaning data, managing CRF and query trends, and data reporting to ensure a clean and complete database ready for lock and/or analysis.
  • Effective and courteous communication of project status, data trends, proactive and remedial issue resolution. Attendance and participation at study team meetings.
  • Develops, generates, and analyze project status and progress reports, including reporting summaries of findings/cleaning status as well as remedial activities to project team.
  • Review clinical study protocols and statistical analysis plans and ensure data quality for analyses
  • Work with biostatisticians and SAS programmers to ensure data is collected with CDISC data standards in mind. Knowledge of CDASH and CDISC data structures.
  • Ensure regulatory compliance of vendors and investigational sites with GCP, SOPs, FDA and ICH guidelines, 21 CFR Part 11 and other applicable regulations, as they pertain to DM activities. Participate in regulatory and CRO/vendor audits for programs and projects.
  • Manage competing priorities across multiple studies.
  • Work independently and exercise appropriate judgement.
  • Assist in compilation of clinical data for regulatory submissions.
  • Ability and willingness to travel up to 15% of the time, including domestic and international travel (depending on applicant location).

Basic Requirements:

  • BS or MS in data management or related field preferred
  • At least 5-years of experience working in Biotech/Pharmaceutical/CRO industry across the development lifecycle

Additional Preferences:

  • Direct experience in oversight of data management vendors
  • Experience in neurodegeneration or rare diseases and in gene therapy
  • Adequate levels of IT, data management, and programming skills
  • Strong oral and written communication skills.
  • Able to function effectively in an individual and team environment.

Additional Information:

  • Position Location: New York or remote possibilities


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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company.  If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com. 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25381.

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.

Apply NowApply Later

About Science

Our scientists and researchers are developing the breakthrough medicines of tomorrow. Join us and become a creative innovator and thinker who can improve the lives of millions.

Recruiting Events

We’d love to meet you to discuss career opportunities. Check our calendar now to see when we’ll be in your area.

View All Events

Stay Connected

Job Alerts

By signing up for job alerts, you’ll be the first to learn about opportunities that could be a great fit for you via periodic email updates.

Sign Up

Join Our Talent Community

Share a bit about yourself, such as the career area you are interested in. We will then reach out to you when the perfect position is available!

Sign Up

Sign Up

Areas of InterestSearch for a category, location, or category/location pair, select a term from the suggestions, and click "Add.”