As a dynamic multinational tech company operating in 50 countries, we drive innovation, create projects that shape the future, and greatly enhance quality of life. You will find our solutions in the space industry, supporting scientists in the development of cancer drugs, and implementing innovative technological solutions for industrial clients worldwide. These are just some of the areas in which we operate!
Currently, for the new Seargin project, we are looking for a: IT Business Analyst!
Role: IT Business Analyst
Contract: B2B (Autonomo)
Sector: pharma
Seniority: Mid/Regular
Location: hybrid from Barcelona, Spain
Availability: ASAP or 1 month
Contract Duration: 1 year
Languages: Excellent English and Spanish
Recruitment Process: 1 stage
About the position:
Responsibilities
1. Collaborate with stakeholders in clinical development to identify and document business and functional requirements for IT systems.
2. Translate clinical development needs into detailed IT specifications, focusing on systems such as EDC (Electronic Data Capture), eTMF (electronic Trial Master File), and CTMS (Clinical Trial Management System).
3. Process Mapping and Optimization: Map out and document current clinical development processes, identifying inefficiencies or opportunities for improvement.
4. Propose and implement IT solutions to optimize clinical trial processes, enhancing efficiency and data quality.
5. System Implementation and Integration: Evaluate, recommend, and support the implementation of IT systems that meet the needs of the clinical development team.
6. Ensure successful system integration, data migration, and customization, working closely with IT and clinical teams.
7. Stakeholder Management: Understand customer and key stakeholders' interests and concerns and guide and provide solutions to customers and key stakeholders.
8. Assist in change management processes, providing support during transitions to new systems or processes.
9. Prepare presentations and concepts to be presented to the functional community or leadership team.
10. Validation and Compliance: Lead or participate in system validation activities to ensure compliance with industry regulations (e.g., GxP, 21 CFR Part 11).
11. Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues.
12. Training and Support: Develop and deliver training materials and sessions for clinical development teams, ensuring effective use of IT systems.
13. Provide ongoing technical support and troubleshooting, working with IT support teams as needed.
14. Data Management and Reporting: Collaborate with data management teams to ensure high data quality in clinical systems.
15. Define reporting requirements and assist in designing reporting solutions that provide insights into clinical trial progress.
16. Project Management: Coordinate IT projects within the clinical development area, ensuring timely and within-budget delivery.
17. Identify and mitigate project risks, maintaining a proactive approach to problem-solving.
18. Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development.
19. Propose innovative IT solutions to enhance clinical trial efficiency, data integrity, and patient safety.
20. Collaboration with Vendors: Manage relationships with external vendors, participating in the evaluation, selection, and management of third-party software and service providers.
21. Assist in contract negotiations and reviews to ensure alignment with business and technical requirements.
22. Management Responsibility: Individual contributor who may manage employees (rarely) and may review the work and supervise other junior employees and validate peer's work (including external suppliers).
Requirements:
1. Proven experience as an IT Business Analyst in the clinical development or related R&D areas (Medical Affairs, for instance).
2. Strong understanding of clinical trial processes and related IT systems (e.g., EDC, CTMS, eTMF, eISF, RTSM, RBQM, eCOA, eConsent, Imaging) and software development lifecycle (SDLC).
3. Experience managing IT projects in a regulated environment, with knowledge of GxP, 21 CFR Part 11, and other relevant regulations.
4. Fluent in English and Spanish.
5. Excellent communication and stakeholder management skills.
6. Experience with system validation, process optimization, and project management.
7. Familiarity with AI technologies such as natural language processing (NLP), predictive modelling, and machine learning algorithms applied to Clinical or Medical areas.
8. Business Analysis certifications (e.g., CBAP, CCBA) or Project Management certifications (e.g., PMP, PRINCE2) are a plus.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
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