Manager-CSAR-Global Library

Manager, CSAR - Global Library

*What you will do*

The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Companys standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology.

The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change.

The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)..

*Responsibilities include, but are not limited to, the following:*

• 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).

*What we expect of you*

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• Masters degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR)
• Bachelors degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR)
• Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience

Preferred Qualifications:

• Advanced degree in life science, computer science, math, statistics, business administration or related field
• 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 (CROs, central labs, imaging vendors, IRT vendors, etc.)

Knowledge:

• Good Clinical Practice
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking.
• Drug development and clinical trials processes
• Data management processes
• Programming of clinical trial databases and applications
• Systems development lifecycle
• Programming Languages
• Project planning and management
• Quality management
• Regulatory filings and inspections
• Understanding of CDISC and SDTM
• Process improvement methodologies