Are you looking for a role that puts you in the intersection of people, technology and process? Do you want the accountability of ensuring your system is fit-for-purpose for a global business community? Are you energized by the challenge of being the focal point for a system, being the person accountable for inspection readiness and representing the company in an inspection?
If so, we have an exciting opportunity to join us as a Clinical Support Manager to join Integrated Systems Support (ISS) at GSK, where our systems safeguard high quality clinical data which are used for regulatory submissions across the globe. In this role, you will be responsible to ensure that our systems are validated, compliant and remain fit-for-purpose during their entire lifecycle.To facilitate this, our Clinical Support Managers are trained to take on the Business System Owner (BSO) role.Our BSOs harness their knowledge of compliance and regulations to ensure our systems continue to meet the needs of the latest regulations (GDPR, Data Integrity, PII). BSOs also help to shape and influence the evolution of our tools in collaboration with key stakeholders from our business and IT communities. A support analyst who fulfils the BSO role may own one or several systems.
We are looking for someone who is: inquisitive; comfortable with both business processes and technical concepts; possesses high personal integrity; courageous; accountable; thinks broadly at an enterprise level; and able to work with colleagues across a host of geographies and functions.
If this sounds like you, this is a fantastic opportunity that will build upon your skills in: compliance, data quality, vendor management, stakeholder management, project support, operational oversight, strategic focus and customer support!
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you?Basic Qualifications:
- Accountable for ensuring systems are inspection-ready and validated to internal and regulatory expectations (Data Integrity, PII, GDPR, ICH GCP, FDA 21 CFR Part 11, ERES etc.).
- Partner with cross-functional business groups to develop, standardize 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.
- Provide exceptional customer focused support.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Computer Science, Statistics, Life Sciences with proven applicable experience in Pharmaceutical industry
- 5 years+ experience with the Data Management and/or Stats and Programming business functions
- Experience validating computer systems to MHRA/EMA/FDA/PDMA regulatory requirements
- Expert in clinical development processes and procedures, including related functional areas and regulations, as required.
- Experience working effectively with inter-disciplinary teams.
- Must possess a technical background and computer proficiency in a variety of clinical trial systems and databases.
- Experience working on complex and/or multiple project assignments.
If you have the following characteristics, it would be a plus:
- Experience of leading the validation of computer systems within a regulated pharmaceutical environment.
- 3-5 years experience of Biostatistics systems and processes
- Experience working with a data management and/or statistical computing environment
- Demonstrable understanding of regulatory requirements related to sponsor obligations of computer system validation
- SAS/R/Python Programming and Oracle SQL expertise
- Exhibits enhanced customer service orientation and excellent interpersonal skills with ability to communicate professionally to diverse cross functional non-technical and technical audiences.
- Demonstrated ability to manage tasks proactively.
- Familiarity with clinical data flow, data reuse and warehousing concepts
- Experience using and applying CDISC industry data standards (SDTM and ADaM)
- Experience with vendor management and purchased software and over-sight of off-shore support staff would be beneficial
- Familiarity with Agile/SAFe methodology and ways of working
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being .
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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