About Atos
Atos is a global leader in digital transformation with 107,000 employees and annual revenue of over € 11 billion. European number one in cybersecurity, cloud and high performance computing, the Group provides tailored end-to-end solutions for all industries in 71 countries. A pioneer in decarbonization services and products, Atos is committed to a secure and decarbonized digital for its clients. Atos is a SE (Societas Europaea), listed on Euronext Paris and included in the CAC 40 ESG and Next 20 Paris Stock indexes.
The purpose of Atos is to help design the future of the information space. Its expertise and services support the development of knowledge, education, and research in a multicultural approach and contribute to the development of scientific and technological excellence. Across the world, the Group enables its customers and employees, and members of societies at large to live, work and develop sustainably, in a safe and secure information space.
Consultant (multiple positions available)
Reports to company headquarters in Irving, TX.
Maintain clinical and regulatory affairs system application suite, fix existing issues, configure workflows, user roles, permission, document lifecycle settings, integrate vault with other systems, manage change control, document transfer, set up functions, and process information.
Perform system administration activities for GxP applications: Veeva Vault Production Cloud Application systems (Vault eTMF/Clinical, Vault Submissions/Regulatory and Vault Quality Documents), Oracle Siebel Trial Management System, Salesforce, Content Management System, TVT (Text Verification Tool), TMAD Regulatory, DocuSign eSignature, Intelligent Editing.
Perform test case creation including IQ/OQ to validate system functionality and document them for GxP compliance in computer system validation.
Work with business and IT functional users on gathering requirements related to the enhancement for applications used for managing, storing, publishing, and archiving regulatory submissions and related clinical documents.
Coordinate with product vendors on technical issues, possible solutions and enhancements.
Monitor performance and address integration issues or data synchronization failures between Oracle Siebel CTMS, Clinical and regulatory system to reduce manual document reconciliation.
Prepare dashboards and reports to provide regular updates to business on risk and mitigation strategies in the Clinical and Regulatory affairs used in Pharma/Lifesciences Drug Research & Development unit.
Implement, validate, and maintain DocuSign electronic signature solutions with GxP 21 CFR part 11 and Pharma regulatory standards.
Configure and manage DocuSign envelope, templates, user roles and provide training and user support for GxP compliant e-Signature usage across functional departments.
Translate business requirements to understandable IT systems requirements.
Act as liaison between management and development team for requirements and QA.
Prepare high-level technical design and low-level technical design documents for enhancement of applications based on analysis as per procedures and standards.
Develop technical guidelines and service management details to facilitate continuous maintenance and automation.
Participate in application release management activities and provide technical description of application, project, and back out plans.
Provide technical assessment and technical review of changes requested and present them at Change Advisor Board (CAB) meetings.
Coordinate and work with offshore team to explain project requirements and ensure timely deliverable.
Provide technical guidance to the team over application bug fixes and maintenance.
Utilize Agile/Scrum methodology for Agile projects and feature enhancements.
Manage and ensure compatibility with supported file formats, monitor format changes, and import/export issues in using TVT for regulatory document verification.
Support PerfectIT system for self-QC prior to peer or quality review in regulatory document teams across departments and vendors.
REQUIREMENTS: Bachelor’s degree in Computer Science, Information Technology, Engineering (any), or related field of study.
Five (5) years of required Information Technology (IT) experience in Life Sciences and Pharmaceutical field.
Five (5) years of required Information Technology (IT) experience in Life Sciences and Pharmaceutical field must include: Veeva Vault; Salesforce; Oracle Siebel; ServiceNow; DocuSign eSignature; JavaScript; SharePoint; Agile / Scrum methodology.
ROVING/TELECOMMUTING EMPLOYEE: Reports to company headquarters in Irving, TX. Will work at various unknown client sites throughout the U.S. for up to 100% of the time. Must be willing to travel anywhere in the U.S. and may be assigned to work at client sites across the U.S. Can work remotely or telecommute.
SALARY: $141,336.00 - $142,336.00
APPLY: Job ID OGL 011
Here at Atos, we want all of our employees to feel valued, appreciated, and free to be who they are at work. Our employee lifecycle processes are designed to prevent discrimination against our people regardless of gender identity or expression, sexual orientation, religion, ethnicity, age, neurodiversity, disability status, citizenship, or any other aspect which makes them unique. Across the globe, we have created a variety of programs to embed our Atos culture of inclusivity, and work hard to ensure that all of our employees have an equal opportunity to contribute and feel that they are exactly where they belong.
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