Nonclinical Systems Analyst (Temporary) - United States
Want to know company name or location? Company managed [?]
- 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.
- 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.
- 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.
- 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.
- 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.
- Prior experience with SEND or CDISC data standards preferred.
- Experience developing and validating custom web applications.