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Nonclinical Systems Analyst

Essential Duties & Responsibilities (Primary):

  • Manages, administers, supports, and deploys various nonclinical systems such as the Master Schedule and Pharm/Tox SEND database.
  • Authors controlled documents, process documents, including User Requirements Specifications, System Design Documents, System Configuration Documents, and Data Transfer Specifications.
  • Manages implementations and upgrades of nonclinical computer systems.
  • Participates in the development of processes related to the use of nonclinical systems.
  • Authors and reviews SOPs and policies for nonclinical data systems.
  • Develops and deploys training to users for various nonclinical systems.
  • Provides first-level User Support for nonclinical systems.
  • Contributes to inspection readiness activities related to nonclinical systems.
  • Represent Pharmacological Sciences on the Dev. Sci. Technology Advisory Board.
  • Collaborate with internal stakeholder groups (IT-CSV, IT Business Management) in evaluating new systems in the context of business and compliance needs, including the planning, design, configuration, and deployment of new systems and enhancements to existing applications.
  • Manages relevant vendor relationships.

Secondary Responsibilities:

  • Assist in maintaining and managing Pharmacological Sciences BioWeb content and various other duties assigned by leadership or management.

Core Competencies, Knowledge and Skill Requirements:

  • Excellent technical skills and proficiency in working with databases.
  • Familiarity with drug development process, nonclinical and clinical study operations, terminology, and regulations.
  • Must be self-motivating and able to follow direction, prioritize and manage a large volume of work.
  • Must be able to handle a moderate amount of pressure, and show attention to detail.

 

Communication & Interpersonal Skills:

  • Ability to work collaboratively with cross-functional groups with minimal supervision to ensure that the most optimal solutions are achieved in alignment with department strategies.
  • Excellent interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of roles and responsibilities within development sciences.

Required Skills:

  • 5+ years of experience in drug development and understanding of relevant terminology and processes. Working knowledge and experience with GxP, Title 21 CFR Part 11 compliance.
  • 4+ years of experience supporting nonclinical and/or clinical data systems.
  • Prior experience administering SharePoint and Oracle database systems required.

Desired Skills:

  • Prior experience with SEND or CDISC data standards preferred.
  • Experience developing and validating custom web applications.

 

Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals), Data Sciences, or business degree or equivalent.

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