Strategy & Consulting - Global Network - Products - Life Sciences R&D Manager (Xico)

Key Responsibilities

• Requirements gathering and defining acceptance criteria to align with the organization's specific needs and business processes.
• Ensuring data integrity and efficient workflows.
• Providing insightful, deal‑relevant points of view and recommendations based on robust analysis.
• System documentation as per GxP‑compliant SDLC process.
• Delivering end‑user support, training, and change management to ensure successful technology adoption.
• Monitoring platform updates and managing system upgrades or enhancements as needed.
• Ensuring alignment with industry best practices and regulatory expectations for technology enablement in R&D.

Qualifications

• MBA or equivalent Masters degree in science, or a postgraduate degree with rich and relevant industry experience.
• 10+ years of progressive experience in the Life Sciences industry or consulting, ideally in roles involving business strategy systems implementation or technology transformation.
• Proven experience leading initiatives around Clinical trial systems, Regulatory submission tech, Patient safety reporting platform, and any modern tech solutions to accelerate drug development.
• In‑depth understanding of Life Sciences R&D functions including Clinical Operations, Regulatory Affairs, Quality Assurance, Safety, and related compliance requirements (GxP, 21 CFR Part 11).
• Extensive knowledge and experience in agile methodology‑based technology transformation projects.
• Demonstrated ability to manage multiple concurrent projects, prioritize tasks, and deliver outcomes in a fast‑paced environment with multiple stakeholders.
• Proven ability to effectively plan, manage, and coordinate multiple projects in a dynamic environment with numerous and complex stakeholder groups.
• Excellent documentation skills and exposure to work within GxP‑validated systems.
• Advanced English is mandatory.
• Availability to travel may be required.
• Good to have: Experience in at least 4–5 of the following areas: Clinical Trial Management Systems (CTMS); Regulatory Information Management (RIM); Electronic Trial Master File (eTMF) or Clinical Document Management; Clinical Data Management / EDC; Biostatistics or Clinical Data Analytics; Laboratory Information Management Systems (LIMS); Quality Management Systems (QMS); Pharmacovigilance or Safety Systems.

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