Use experience with: EDC systems; Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices for data management; project management; metrics analysis and reporting methodologies; knowledge of submission requirements, e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA) to provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plan, coordinate, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects. Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members. Provide strong quality and project oversight over third party vendor responsible for data management deliverables. Take a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforce data standard conventions and quality expectations for clinical data per defined processes. Author, review/revise Data Management related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization. Chair Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness. Represent Data Management on cross-functional project teams & submission Teams. Lead or support the Health Authority inspections and audits. Provide coaching and quality oversight of junior Data Management Leads. May telecommute 100% of time from anywhere in the United States.Requirements: bachelor’s degree (or foreign equivalent) in biology, microbiology, statistics, biostatistics or a related field plus 5 years of post-baccalaureate experience reflecting demonstrable ability in the skill set described above.