Manager, CSAR - Global Library

• Support of clinical trial platform technologies
• Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight
• Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems
• Coordinating and providing programming support to Clinical Study Teams
• Maintaining standard business processes within GDO to ensure compliance to regulatory bodies
• Acting as a technical point of contact for systems deliverables on defined programs
• Providing technical and business process input / expertise on new and emerging technologies
• Develop, review and implement policies, SOPs and associated documents
• Assist in preparing for and responding to audit findings (internal or external)
• Provide Global Library review at the study level
• Coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES)
• Provide database design services to clinical study teams
• Ensure the standards libraries are maintained appropriately
• Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology
• Partner effectively with other CSAR Operations and cross functional staff
• Responsible for quality and results at the study and library level
• Help deliver large system transformation projects

• Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience
• Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience
• Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience
• Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
• General project management and planning experience
• Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
• Good Clinical Practice knowledge
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
• Knowledge of drug development and clinical trials processes
• Knowledge of data management processes
• Knowledge of programming of clinical trial databases and applications
• Knowledge of systems development lifecycle
• Knowledge of Programming Languages
• Knowledge of project planning and management
• Knowledge of quality management
• Knowledge of regulatory filings and inspections
• Understanding of CDISC and SDTM
• Knowledge of process improvement methodologies

Advanced degree in life science, computer science, math, statistics, business administration or related field

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards