EDC Business System Owner
This role can be based at Stockley Park, Ware or Stevenage
Are you looking to take the next step in your career in product ownership and computer system validation? Do you want an opportunity that will stretch your ability to solve problems, manage vendors and improve how we operate? Do you want the accountability of owning global clinical trial systems? Do you want to be part of team that values teamwork and the skills you bring that make you unique? If yes, this could be the opportunity for you!
Within GSK R&D, we have a dedicated organisation charged with ensuring that our clinical systems are validated, compliant and remain fit-for-purpose during their entire lifecycle. To ensure that our systems continue to meet the needs of our users and the latest regulations (e.g. GDPR, Data Integrity, PII) our department comprises of expert Business Systems Owners (BSO). Our BSOs are accountable for the product roadmap, inspection readiness and support of our systems. BSOs help to shape and influence the evolution of our tools in collaboration with key stakeholders from our business and IT communities.
The successful candidate shall partner with our EDC (Oracle InForm) BSO to deliver exceptional ownership and support of this critical clinical trial application. The successful candidate will be additionally expected to own an application(s) of their own.
Successful candidates are typically inquisitive, comfortable with technical concepts, possess high personal integrity, courageous, accountable, able to work with colleagues across a host of geographies and functions and have a burning desire to improve processes that help fulfil GSK's purpose of helping people to do more, feel better and live longer.
This is a fantastic opportunity to join a team that give you accountability early on, will stretch your ability to manage problems (and opportunities!), build your product and vendor management skills as well as strengthening your experience of computer system validation in a pharmaceutical environment.
• Accountable for maintaining the system in an inspection-ready state and validated according to the level of risk and GCP compliance required
• Ability to manage both external vendors and internal partners in a matrix leadership environment with frequently conflicting timelines and priorities
• Responsible for maintaining System Audit/Assessment readiness and support
• Partner with one or more cross-functional business groups to develop, standardise, improve and maintain business, technical and system functionality and processes to achieve business benefits
• Serve as a point of contact for questions related to assigned functional area(s), assigned system(s) and areas of expertise for internal and external customers, as appropriate
• Ability to communicate effectively with global audiences with varying degrees of technical understanding
• Responsible for ensuring that their system's functionality and performance are aligned to the business requirements set out by the assigned user group and delivered accordingly
• Possess global view of system(s) and be able to represent implications of system changes across multiple customer groups
• Ensure data integrity is maintained through all system versions
• Understand the system landscape and the impact of changes in downstream systems across multiple customer groups
• Possess knowledge of the System Development Life Cycle, especially in User Acceptance Testing
• Display strong understanding of the needs of application support (e.g. enhancements versus bugs, scheduled downtimes versus unscheduled downtimes)
• Possess knowledge of quality management, computer compliance, and computer system validation in a regulated environment
• Ability to problem solve and think outside the box, while still adhering to regulatory requirements
• Apply knowledge, experience and leadership skills in execution of job responsibilities
• Be customer focused (i.e. know when to apply a sense of urgency, apply flexible thinking and strong communication skills)
• Basic project planning skills
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 15th January 2019
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
• Bachelor's degree in computer science, Statistics, Life Sciences
• 5 years of experience in the implementation and support of electronic data capture (EDC) tools
• Significant experience of computer system validation and quality management systems within a regulated pharmaceutical environment
• Practical experience of computer system change and release management processes
• Demonstrated ability to deliver impactful process improvements
• Proven ability to influence and drive technical and non-technical cross functional teams
• Able to demonstrate good knowledge of processes, procedures and regulations (GCP, ICH, FDA CFR Part 11) related to clinical data management
• Oracle InForm technical support experience
• Deep understanding of Oracle's InForm EDC product - able to articulate how its configuration, implementation and integration impacts business processes
• Experience of leading the validation of computer systems within a regulated pharmaceutical environment
• Demonstrable understanding of the regulations and international requirements that govern sponsor obligations regarding computer systems
• Clinical Data Management experience
• Ability to effectively prioritise and consistently deliver high quality deliverables in a fast paced and complex environment
• Independent self-starter - manages tasks proactively and adapts to changes quickly
• Practical experience of the end-to-end software development life cycle (SDLC)
• Proven ability to deliver precise, succinct and impactful written communications
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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