Consultant (multiple positions available)

Atos•Irving, SD

1d•$141,773 - $142,773•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Life Sciences, Biomedical, Healthcare Administration, or related field of study.
Five (5) years of experience in any occupation with clinical research and operation experience, or related.
Five (5) years of required clinical research and operation, or related experience must include: Clinical Trial Management System (CTMS) such as: Oracle Siebel, Medidata Rave; Electronic Trial Master File such as: eTMF, Veeva Vault; Data Quality Tool Tableau; Regulatory requirements such as: GxP guidelines, ALCOA+ Principles, FDA regulations, ICH-GCP guidelines; Electronic Data Capture (EDC).
Master’s degree in Information Technology, Computer Science, Life Sciences, Biomedical, Healthcare Administration, or related field of study and 3 years of experience in any occupation with clinical research and operation experience, or related. Must have skills listed above.

Responsibilities

Define and implement standardized global workflows, organizational-specific SOPs, Oracle Siebel Clinical Trial Management System (CTMS) modules and fields for data entry, validation, and system maintenance, significantly minimizing operational discrepancies, which adheres to GxP pharmaceutical compliance.
Author and maintain accurate and timely system documentation for actions such as system configuration, and complex data resolution, ensuring validation and quality check, data integrity (ALCOA+ principles), security, audit trails, and data archiving that supports immediate inspections and audits.
Ensure Enrollment Data quality and sequential milestone dates by actively oversighting, to ensure Compliance to ICH-GCP guidelines and FDA’s 21 CFR Part 11 regulation.
Act as the primary Clinical Trial Management System (CTMS) point of contact for technical and safety teams and efficiently coordinate Site Setup, Account Additions, and processing complex CRO integration errors for resolution as per Pharma Regulatory compliance.
Conduct Root Cause analysis by collaborating with Study Business Administrators and other operations members to resolve data discrepancies and data cleaning as per the Quality Check in the Clinical Trial Management system.
Responsible for regular project monitoring, metrics preparation and status reporting, and ensure compliance with Good Clinical Practice (GCP) to senior management.
Monitor data performance and address integration issues or data synchronization failures.
Proactively identify and drive continuous improvement initiatives for Clinical Trial Management system functionalities and associated workflows and expected to deliver measurable increases in efficiency and data management standardization.
Maintain the Master study portfolio for all Integrated and Non-Integrated Clinical studies from Phase 1 to 3 studies using Interactive Response Technology (SUVODA and ALMAC) reports. This includes owning all system Milestone activities (from Site Activation to Close-Out across Study, Region and Site), validating reference data adhering to GxP guidelines.
Ensure and oversight accurate Principal Investigator assignment data and Site Contacts information across systems such as Med PACE Clintrak, Safety Vigilance, and the Clinical Trial Management system.
Develop and execute training plans and knowledge transfers for new hires to ensure team proficiency in Clinical Trial Management System Data oversighting as per Good Clinical Practice (GCP) compliance standards.
Manage, process, and provide resolution for all Safety Vigilance and Clinical Trial Management support tickets within the Service Now platform.
Coordinate and work with offshore team to explain project requirements and ensure delivery time. Provide technical guidance to the team over application bug fixes and maintenance.