Manager, CSAR - Global Library

Manager, CSAR - Global Library

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

• Operational experience with clinical database management systems and allied technologies (e.g.,

  Rave EDC, Veeva EDC

  ).
• Strong understanding and experience with

  Good Clinical Practice

  , drug development, and clinical trials processes.
• Knowledge of

  CDISC

  and

  SDTM

  .
• Experience in programming of clinical trial databases and applications.
• Understanding of the systems development lifecycle, project planning, and management.
• Broad knowledge or work experience in data management/programming in the Pharmaceutical or Biotech arena.
• Experience in oversight of outside vendors (

  CROs

  , central labs, etc.) is a plus.

Qualifications

• A Master's degree, Bachelor's degree, or Diploma in life science, computer science, business administration, or a related field.
• An advanced degree is a plus.

Soft Skills

• Leadership:

  A strong leader with a proven ability to influence partners and effectively manage teams.

• Problem-Solving:

  Strong understanding and experience in using performance management techniques and analytical thinking.

• Communication:

  Excellent verbal and written communication skills, with a focus on collaborating effectively with global, cross-functional teams.

• Proactiveness:

  High degree of initiative and self-motivation, with the ability to manage multiple priorities successfully.

• Teamwork:

  Team-oriented, with a focus on achieving team goals.