[Hiring] Business System Owner @1054 GlaxoSmithKline Services Unlimited
Mar 17, 2025 - 1054 GlaxoSmithKline Services Unlimited is hiring a remote Business System Owner. đź’¸ Salary: unspecified. đź“ŤLocation: UK.
Role Description
We are seeking an experienced Business System Owner (BSO) to join our Integrated Systems Support (ISS) department within Global Clinical Operations. Our goal is to ensure our systems operate flawlessly, are validated, compliant, and fit-for-purpose. We have a relentless focus on the patient, and we challenge ourselves to innovate to accelerate the delivery of our clinical trials. BSOs are critical in shaping the evolution of our systems in collaboration with key stakeholders across the company. They are ultimately accountable for the validation status of our systems. Our BSOs connect people, technology, and process. They possess a broad understanding of the clinical trial execution, business processes, the software development lifecycle, and computer system validation regulations.
- Lead development of strategy and roadmap to develop, release and maintain compliant and user-friendly systems for partner functions to efficiently execute business processes.
- Collaborate with business leaders, stakeholders, SMEs, and user groups to develop business requirements and insights, and to assess the impact of system changes.
- Drive system development and data quality strategy & oversee execution.
- Represent system in internal audits & external inspections and ensure timely completion of corrective actions (CAPAs).
- Ensure compliance with industry regulations and GSK requirements, including proper validation and documentation.
- Manage system lifecycle including risk management and mitigation.
- Develop strategic partnerships with internal and external stakeholders.
- Maintain vendor oversight and ensure vendors comply with GxP standards.
- Monitor and resolve system issues, communicate proactively with users, and escalate significant concerns as needed.
- Ensure day-to-day system operations, governance, and risk management.
- Maintain process maps, user documentation, training, and communications.
- Oversee support service and help desk operations ensuring efficient system access and effective issue resolution.
- Classify and control data quality according to GSK policies.
- Establish metrics demonstrating data quality.
Qualifications
- Significant experience of validating systems to regulatory requirements (GCP, FDA 21 CRF Part 11 etc)
- Experience of managing/owning global systems with different levels of complexity
- Extensive track record of influencing and/or collaborating with software vendors, business and tech delivery partners.
- Substantial experience of identifying and delivering impactful technical and process improvements.
- Experience of representing sponsor company in regulatory inspections.
- Strong communication skills across geographies and functions.
Requirements
- Bachelor’s degree in Computer Science, Statistics, Life Sciences (preferred)
- Project Management experience (preferred)
- Change Management experience (preferred)
Benefits
- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Hybrid working model through Performance with Choice programme
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| đź“Ť | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
đź’¸
unspecified
|
Remote
Location
UK
|
|
Job Type
full-time
|
Posted
Mar 17, 2025
|
| đź“Ť | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
