We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
The individual is responsible for the design, development, testing, validation, execution, and maintenance of clinical studies in the RAMOS Interactive Response Technology (IRT) system, ensuring data integrity and driving continuous improvement across all Clinical Supplies systems, and overseeing Clinical Studies by non‑GSK IRT Vendors.
Key Responsibilities
- May include supervising staff.
- Assess planned studies for suitability for RAMOS IRT system.
- Independently configure and manage/maintain complex IRT study designs, possibly those with an international, adaptive, or more complex design.
- Proactively identify and communicate issues and provide proposed solutions.
- May serve as IRT group business point of contact for technical systems (Randomization and Container Code, Packaging, and Shipping Systems).
- Responsible for drafting, amending, and determining gaps in SOPs.
- Raise deviations/customers complaints and associated CAPAs.
- Assist with Helpdesk during daytime hours as needed, and participate in Helpdesk stand‑by/on‑call rotations (nights, weekends, holidays).
- Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
- Analyze data and drive/implement continuous improvements.
- Provide technical guidance/support to Clinical Development for their outsourced IRT studies.
- Lead interactions with RDIT for operational system issues and drive future IRT enhancements.
- Develop supply strategy to eliminate stockouts, minimize waste, and reduce shipments.
Basic Qualifications & Skills
- Understanding of the development process and clinical supplies; demonstrates fundamental knowledge of PDS – CSC computer systems.
- Ability to maintain accurate records and files in accordance with GSK policy, cGMPs, and SOPs.
- Proven computing skills and experience with various software: Excel, Word, PowerPoint, Visio, MS Project, etc.
- Proven ability to work in a matrix team and independently, with strong attention to detail and multi‑tasking capabilities.
- Ability to train others inside and outside the workgroup in area of expertise.
- Experience in working with customer relations.
- Excellent oral and written communication skills, good interpersonal skills, and good planning and coordination skills.
- Creative and innovative thinking, strong problem‑solving skills, and a drive for continuous improvement.
- Scientific degree or equivalent experience related to IRT or clinical supplies.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service, or any basis prohibited under federal, state, or local law.
We welcome applications from people with different backgrounds and experiences.
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