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Lilly Associate Director Clinical Data Management in United States

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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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