IT Business Analyst II, Clinical
See your future through a different lens
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Responsibilities include but are not limited to:
· Serve as functional resource and subject matter expert for Clinical Information Management System(s).
· Act as a true liaison for clinical stakeholders and IT teams.
· Quick learner, acting independently without needing any supervision to determine methods and procedures on new or special assignments.
· Participates in projects with varying levels of complexity.
· Participate in creating business cases, make recommendations on vendor selection, and oversee vendor activities including working with managed services vendor for day-to-day activities.
· Collect, document, and manage user, functional, and technical requirements for clinical information management systems.
· Work closely with vendors right from gathering business needs to production roll out and support planning and execution.
· Act as a system administrator for various clinical systems.
· Provide advice, guidance, and training on the systems. Develop training material and provide hands on training to end users.
· Hands on experience in authoring and approving applicable documentation such as IT SOPs, WIs.
· Hands on experience managing veeva application related administrative activities such as onboarding and offboarding end users, configuring workflows, configuring security roles, configuring objects, creating reports and dashboards etc.
· Provide support and knowledge expertise on computer system validation and/or qualification of the platform by closely working with CSV team and QA team.
· Manage application configuration changes and enhancement(s) for GxP as well as non-GxP systems by following appropriate change control procedures.
· Good understanding and knowledge of Service Now Application with ability to create service tickets, assigning them to correct assignment groups and closing the tickets.
· Troubleshoot technical issues and manage problems through to resolution if applicable.
· Document common resolutions and or solutions and application support processes in the IT service management knowledgebase
· Participates in system release management and post-deployment support activities with CSV, Quality, System Owner, Business Owner, vendor(s), and other internal IT teams as applicable.
· Participate in system audits and or regulatory inspections if and as applicable.
· Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions.
· Bachelor or masters or equivalent qualification level, preferably in computer science, engineering, biotechnology or biological science or equivalent combination of education and experience is required.
· IT-related certification or equivalent experience.
· Business Domain knowledge in Clinical is highly desirable.
· Minimum 5 years of working experience in clinical system implementation and project management is preferred.
· Practical knowledge and application of GxP (industry experience/awareness) especially relating to clinical and quality assurance processes and procedures.
· Must possess excellent verbal/written communication skills, stakeholder management, customer service, problem solving and troubleshooting skills.
· Experience with regulatory inspection, audit readiness, data integrity, ITIL, or other IT good practices is desirable.
· Knowledge of GDPR, HIPAA, Computer System Validation (CSV), and GAMP5 experience is a MUST.
· Practical knowledge of SDLC principles, industry best practices, and assigned system(s).
· Hands on experience working on validated and regulated system(s) is highly desirable.
· Experience with any of the following Clinical technologies highly desirable: eTMF, CTMS, Medidata/RAVE, IRT/IVRS, Clinical Data repository, Clinical trial Supply management, sample management, Oracle/SQL, SAS, Clinical Data exploration tools like Spotfire, Power BI, MicroStrategy, QlikView, JMP and-or J-review etc.
· Knowledge of Veeva platforms (ex. eTMF, CTMS) is highly desirable. Veeva Vault certification is highly desirable
· Strong technical background with understanding of SaaS application /COTS products, hands on experience on technologies and languages e.g., BOX, QUMAS, Veeva Quality docs, AWS, SharePoint, Service Now or other Cloud based platforms.
· Travel to Gaithersburg site may be required. (If and as applicable depending on the business need)
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you are fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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