Nonclinical Systems Analyst
Novato, CA | Contract
Bayside Solutions is seeking a Nonclinical Systems Analyst to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Nonclinical Systems Analyst
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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 BioWeb content and various other duties assigned by leadership or management.
- Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals), Data Sciences, or business degree or equivalent.
- Prior experience with SEND or CDISC data standards preferred.
- Experience developing and validating custom web applications.
- 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.
- 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.
- 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.