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 studies. This 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 experience. Applicant may be office based in New York or remote with previously demonstrated capability. The position reports to the Associate Director Clinical Biostatistics.
- 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).
- 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
- 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.