Manager, CSAR - Global Library

As the Manager, CSAR - Global Library , you will report to the Senior Manager of Clinical System and Analytical Reporting and will focus on supporting Global Library activities. This role is a blend of leadership and individual contribution, where you will provide database design services to clinical study teams, maintain standard libraries, and ensure adherence to Data Element Standards (DES) . The ideal candidate will be a strong leader with proven ability to influence stakeholders, and will contribute to large system transformation projects while ensuring high-quality deliverables.

Roles & Responsibilities

• Global Library Management : You will provide Global Library review at the study level, coordinating closely with the Lead Data Manager. You will maintain standard libraries and provide database design services to clinical study teams in alignment with company standards. This includes creating and maintaining standard CRFs and Edit Checks in CDMS (RAVE) or other related technology.
• Technical Leadership & Collaboration : You will act as a technical point of contact for systems deliverables and provide programming support to Clinical Study Teams. You will offer technical and business process input on new and emerging technologies, and act as a data scientist to bring awareness to patterns and analytical insights.
• Process & Quality Assurance : You will lead or coordinate the definition of studies in clinical trial databases and systems. You will also maintain standard business processes within Global Development Operations ( GDO ) to ensure compliance with regulatory bodies. This includes developing, reviewing, and implementing policies, SOPs , and associated documents, as well as assisting in preparing for and responding to audit findings.
• Project Management : You will help deliver large system transformation projects, with a focus on project management, partner engagement, and organizational change.

Technical Skills & Knowledge

Qualifications

Soft Skills

Skills Required

Technical Leadership, Quality Assurance, Clinical Practices, Library Management, Project Management