Clinical Development IT Systems Specialist
hace 2 semanas
We are seeking an experienced IT Business Analyst to support our R&D Clinical Development team at Galderma Pharma S.A. in Barcelona, Spain.
**Key Responsibilities:**
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Continuous Improvement: Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development.
Estimated Salary: €60,000 - €80,000 per year
Galderma Pharma S.A offers a competitive salary, along with additional benefits such as medical insurance, retirement plan, and paid time off. We prioritize work-life balance and encourage professional growth and development. If you are a motivated and detail-oriented IT Business Analyst looking for a challenging opportunity, please consider this position.
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