Capability Development Specialist

Capability Development Specialist supporting Takeda India through ICON. The role works with GDO, R&D and cross-functional stakeholders to elicit requirements and align trial data capabilities with the Trial Data Delivery Strategy. Responsibilities include building collaborative relationships with BPO/PEL and data initiative leads; providing leadership to advance trial data maturity and data quality; defining functional capabilities aligned with GDO business and strategic priorities; advising stakeholders on requirements and solution prioritization; executing and integrating small- to large-scale changes in project data delivery; applying sophisticated analytical approaches and independent judgment to identify opportunities for process improvement; ensuring compliance with company policies, Takeda Quality Management Systems, Software Development Life Cycle and Project Life Cycle standards; independently handling complex issues; establishing relationships across Takeda; analyzing issues and guiding solution development; and maintaining key business-stakeholder relationships. The role requires a bachelor's degree or equivalent, with an advanced degree preferred, and 5+ years of business analysis, data analysis, data transfer or data modelling experience, or 6+ years relevant experience in lieu of a bachelor's degree. At least 3 years of life sciences experience is preferred, particularly clinical trial management/operations. Strong pharmaceutical industry knowledge, clinical trial operations knowledge, GxP requirements including 21 CFR Part 11, validation methodologies, data-environment assessment, communication, presentation and cross-functional collaboration are required. ICON offers competitive total rewards, performance incentives, health and wellbeing programs, retirement/pension plans, life assurance, disability coverage, employee assistance resources and learning/development opportunities, subject to role and location.