Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Review CDISC specifications for SDTM and ADaM datasets and Pinnacle 21 validation reports Provide QC oversight of CRO deliverables like ADaMs, and tables, listings, and figures Develop SAS or other programs/specifications for production of output to support study needs (publications, safety reporting, ad hoc analyses in a timely fashion, etc.) Verify other programmers' re

Supervise the MQA and Aseptic Mentor teams that support all production/processing areas Develop and monitor appropriate KPI's Manage department resource planning, talent development, and budget administration with regards to MQA and Aseptic Mentor personnel, equipment, and facilities Investigate product complaints/manufacturing discrepancies for manufactured products and

Review/approve master batch records, master labeling records, product specifications, stability protocols, stability reports, and other process related documents from contract sites Perform batch disposition through batch record and data review/approval Manage process deviations for timely release Ensure manufacturing and testing organizations (Contract Manufacturing Orga

Lead clinical data management delivery Compile weekly sample status metrics and/or any other study specific metrics/reports Develop and maintain data management documents Act as the point of contact for Data Management on assigned studies for internal/external audience of various management levels Apply a data driven approach to assigned work by utilizing company standard

Manage clinical studies according to company Standard Operating Procedures and Regulatory Guidelines Implement project plans and assigned duties Supervise CROs and CRA's EXPERIENCE Minimum of 5 years of monitoring experience with Phase I III trials required Knowledge of DSG clinical trial software preferred Experience in Rare Disease/Orphan Status Studies preferred Monito