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We are seeking a highly skilled Technical Lead to own and advance our portfolio of Clinical applications. The role will serve as the primary technology partner to the Clinical Operations, Patient Supply, and Biostatistics teams, ensuring our systems are reliable, compliant, scalable, and aligned with our scientific and operational goals. You will play a key role in both the implementation of new application modules and ongoing operational support, including defining requirements, designing solutions, performing application configuration, system documentation, testing, and integration activities. As a growing biotech we are seeking a hands‑on leader who can balance strategy with execution— going beyond simple requirements elicitation to help define solutions that anticipate future needs, leverage knowledge of industry trends, and ensure scalability.
Job Responsibility:
Act as the primary liaison between Clinical teams and IT
Lead the implementation, enhancement, and support of Clinical IT systems
Shape the clinical systems landscape in partnership with Clinical stakeholders and IT leadership
Manage system roadmap development, evaluation and selection of new technologies, and integration of relevant systems
Gather and document business requirements and ensure these are translated into high quality technical solutions
Lead continuous improvement efforts for existing systems
Partner closely with business stakeholders to collect and prioritize enhancement requests
Stay up to date on new technologies and best-practices and make recommendations for potential improvements
Support validation and change management activities, including contributing to requirements documentation, test scripts, and change control documentation
Serve as primary operational support to resolve any system related issues
Support the larger IT organization by assuming other duties and responsibilities, as assigned
Requirements:
6+ years of experience implementing IT systems within the life sciences industry
Demonstrated experience with and strong understanding of one or more Clinical systems (IRT/RTSM, eTMF, CTMS, SAS, clinical dataset generation and validation)
Strong understanding of Computer Systems Validation (CSV), GxP, and 21 CFR Part 11 regulations
Excellent communication, facilitation, and stakeholder‑management skills
Proven ability to lead cross‑functional initiatives and manage vendors