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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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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GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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