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Nonclinical Systems Analyst (Temporary) - United States  

Company managed [?] Still accepting applications
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Posted on : 02 June 2017

Project Description

  • Our company  is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. 
  • Our company will continue to focus on advancing therapies that are the first or best of their kind. 

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 Bio
  • Web 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.

Equal Opportunity:       
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.