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IT Business Analyst – Clinical Development

Location: Barcelona

Job Description

We are looking for an experienced IT Business Analyst to support our R&D Clinical Development team. In this role, you will be responsible for bridging the gap between IT and clinical research teams, ensuring that our technology solutions effectively support our clinical trial processes. The ideal candidate will have a strong background in both IT and clinical development, with the ability to translate complex business needs into actionable IT requirements.

Key Responsibilities

1. Requirements Gathering and Analysis: Collaborate with stakeholders in clinical development to identify and document business and functional requirements for IT systems. 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).
2. Process Mapping and Optimization: Map out and document current clinical development processes, identifying inefficiencies or opportunities for improvement. Propose and implement IT solutions to optimize clinical trial processes, enhancing efficiency and data quality.
3. System Implementation and Integration: Evaluate, recommend, and support the implementation of IT systems that meet the needs of the clinical development team. Ensure successful system integration, data migration, and customization, working closely with IT and clinical teams.
4. Stakeholder Management: Understand customer and key stakeholders' interests and concerns and guide and provide solutions to customers and key stakeholders. Assist in change management processes, providing support during transitions to new systems or processes. Prepare presentations and concepts to be presented to the functional community or leadership team.
5. Validation and Compliance: Lead or participate in system validation activities to ensure compliance with industry regulations (e.g., GxP, 21 CFR Part 11). Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues.
6. Training and Support: Develop and deliver training materials and sessions for clinical development teams, ensuring effective use of IT systems. Provide ongoing technical support and troubleshooting, working with IT support teams as needed.
7. Data Management and Reporting: Collaborate with data management teams to ensure high data quality in clinical systems. Define reporting requirements and assist in designing reporting solutions that provide insights into clinical trial progress.
8. Project Management: Coordinate IT projects within the clinical development area, ensuring timely and within-budget delivery. Identify and mitigate project risks, maintaining a proactive approach to problem-solving.
9. Continuous Improvement: Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development.