InForm Support Analyst
This role can be based at Stockley Park, Ware or Stevenage
Are you an experienced InForm support professional? Do you want to take the next step in your career and broaden your accountability? Are you energised by solving problems that are a mixture of people, process and technology within a faced paced environment?
If yes, this is a fantastic opportunity that will utilise your problem management skills and build your expertise in product management, vendor management and computer system validation in a pharmaceutical environment.
Within GSK R&D, we have a dedicated organisation that ensures 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 (GDPR, Data Integrity, PII) our support analysts are trained as 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 InForm BSO to deliver exceptional ownership and support of this critical clinical trial application as well as acting as the BSO of their own applications.
Successful candidates are typically, inquisitive, comfortable with technical concepts, possess high personal integrity, courageous, accountable and able to work with colleagues across a host of geographies and functions.
• In partnership with the InForm BSO, provide exceptional customer focussed support.
• Accountable for ensuring systems are inspection-ready and validated to internal and regulatory expectations (GCP, FDA CFR Part 11 etc).
• Partner with cross-functional business groups to develop, standardise and improve technical business processes and/or influence system changes that either increases quality, compliance, productivity or reduces risk.
• Ensure data integrity is maintained throughout the lifecycle of a system.
• Represent a system as the Business System Owner in internal audits and external inspections.
• Develop and maintain computer system validation documentation throughout the lifecycle of a system. Able to manage / lead complex User Acceptance Testing assignments.
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: 1st Feb 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.
• Solid Oracle InForm (EDC) support experience.
• Computer system validation experience.
• Demonstrated ability to deliver impactful process improvements.
• Bachelor's degree in Computer Science, Statistics, Life Sciences.
• 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.
• Clinical Data Management experience.
• Able to demonstrate good knowledge of processes, procedures and regulations (GCP, ICH, FDA CFR Part 11) related to clinical data management and sponsor obligations relating to computer systems.
At GSK we are leaders in what we do - our pharmaceuticals business is made up of innovative and established medicines and holds leading positions in respiratory disease and HIV, in 2015 we distributed more than 690 million doses of vaccines to over 150 countries, and our Consumer Healthcare group has a portfolio of some of the world's most trusted and bestselling brands. As a company our mission is to help people do more, feel better, live longer.
We offer a competitive salary package including on target bonus, shares, private medical insurance, a company pension plan, generous annual leave and a commitment to your personal development.
We look forward to receiving your application!
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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