Clinical Development IT Project Lead
hace 23 horas
Galderma is a leading dermatology company with a presence in approximately 90 countries. We deliver an innovative portfolio of premium brands and services through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Our focus on meeting individual consumer and patient needs has driven our success since our foundation in 1981. We prioritize superior outcomes in partnership with healthcare professionals and advance dermatology for every skin story.
We are seeking an experienced IT Business Analyst to support our R&D Clinical Development team in Barcelona. As a key member of our team, you will bridge the gap between IT and clinical research teams, ensuring that technology solutions effectively support our clinical trial processes.
Key Responsibilities
- 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 EDC, eTMF, and CTMS systems.
- 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 them to solutions. Assist in change management processes, providing support during transitions to new systems or processes.
- Validation and Compliance: Lead or participate in system validation activities to ensure compliance with industry regulations (GxP, 21 CFR Part 11). Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues.
Required Skills and Qualifications
- Proven experience as an IT Business Analyst in clinical development or related R&D areas.
- Strong understanding of clinical trial processes and related IT systems (EDC, CTMS, eTMF).
- Experience managing IT projects in a regulated environment, with knowledge of GxP and other relevant regulations.
- Fluent in English, excellent communication, and stakeholder management skills.
- Business Analysis certifications or Project Management certifications are a plus.
Benefits
- You will receive a competitive compensation package with a salary range of €60,000 - €80,000 per year, depending on your experience and qualifications.
- Extended benefit package.
- Hybrid work culture.
- Participate in feedback loops and establish a personalized career path.
About Us
At Galderma, we value diversity and inclusion. We believe in delivering better outcomes by reflecting the perspectives of our diverse customer base. Join us to contribute to shaping the future of dermatology
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