Vice President, Data Management (US)
Prilenia, United States +1
The role
The Vice President, Data Management, Chief Data Scientis will lead the strategy, build-out, and execution of clinical data management across the company’s clinical development portfolio, with direct responsibility for ensuring that data supporting the company’s marketing authorization applications globally are complete, accurate, consistent, and submission-ready. This role owns data management planning, electronic data capture (EDC) systems, data standards (CDISC/SDTM/ADaM), database lock, and CRO/vendor oversight, and partners closely with Biostatistics, Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Quality to ensure the clinical database will withstand Regulatory Authority scrutiny , including pre-approval inspection.
The VP will build and lead a fit-for-purpose data management team (internal staff and/or outsourced functions) and establish the SOPs, systems, and governance needed to scale as the company advances toward and beyond potential approval.