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 diseasesPrevail 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 manager to manage and provide oversight of all data management (dm) activities in our studiesThis position supports our clinical programs by contributing to the collection, cleaning, and reporting of our clinical trial data.
The position title will be commensurate with expertise and experienceApplicant may be office based in new york or remote with previously demonstrated capabilityThe position reports to the associate director clinical biostatistics.
Key responsibilities
Oversight, management, and collaboration with project teams on all dm related aspects of assigned programs and/or projectsAssures 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.gOracle 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 resolutionAttendance 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 mindKnowledge 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 activitiesParticipate 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).
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
Direct experience in oversight of data management vendors
Preferences
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.
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 companyIf you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.
