Project Manager, Clinical Data Management

Clinical Data Management Systems Project Manager Looking for Clinical Data Management background and understandings on data, software deployments, and project plans associated with clinical labs. The processes and workflows associated to developing project plans. Forward thinking of all parties that will be involved and needs associated with plans, infrastructure teams, external vendors, internal stakeholders and teams (CSV, LIMS, validation, business etc). Proven ability and confidence to drive said parties to completion of tasks to remain on time. Strong background specific to clinical labs and validated project plans. Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH) Prior experience with data transfers or management eCRF Specification design and delivery of systems Lead cross-functional study team members and participates in clinical database design User Acceptance Testing (UAT); assist Data Management in oversight of EDC builds by outsourced vendors for the resolution of findings. Monitors the quality of outsourced clinical database clinical biomarker data deliverables Work with cross-functional team members and external vendors to develops best practices for clinical database design, testing and UAT Ensures achievement of clinical database creation and modification deliverables and milestones in coordination with outsourced vendors, data management and cross functional team members for trials. Lead/participate in the implementation and adoption of innovative clinical data management systems (CDMS) for data capture and cleaning. Samprasoft