• Job Description

  Req#: 372600

  The Central Monitoring team is responsible for implementation of Risk Based Quality Management (RBQM) across studies, focus on Centralized Monitoring and Data analytics. They also act as a RBQM advisor to study teams, promotes effective risk planning and processes to proactively identify risk and create effective quality plans.

  Key Responsibilities:

  • Single point of accountability for the application of Risk Based Quality Monitoring (RBQM) aligned with the protocol, GSK SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored studies.; includes the set up and execution of CM and DA tool
  • Subject matter expert (SME) on RBQM and DA (Data Analytic) both internally ( inhouse studies) and externally ( Fully outsourced studies)
  • Lead and oversee CM and DA activities, for a dedicated asset as appropriate: playing role of Asset Lead
  • Accountable for study level data analytics, vendor deliverables and performance; ensure monitoring (CM and site monitoring) mitigations to study and data risks are fit for purpose and included in the appropriate operational plans (e.g. Study Monitoring Plan (MP) and Data Quality Plan (SDQP or Data Management Plans)
  • Mentors and trains, inspires Central Monitors as well as Members of the Central/ Local study teams on RBQM

  Why you?

  Qualifications & Skills:

  • A minimum of 5 years drug development experience in Pharma, relevant CRO and/or ARO
  • Business acumen demonstrated by understanding of risk management, problem-solving, the implications of decisions and uses this knowledge to plan and manage issues, projects and processes.
  • Understanding of RBQM, use of data analytics (e.g. Spotfire RBM Tool)
  • Strong knowledge/experience in project management and matrix team interactions
  • Strong communication/negotiation/facilitation/influencing/coaching skills.
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

  Preferred qualifications & Skills:

  • Demonstrates the discipline of risk-based planning, organizing and managing risks / contingency planning to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.
  • Leads teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
  • Acts as role model in line with GSK core values and behaviors; willingness to mentor/train staff in central monitoring and data analytics and other related positions.
  • Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of GSK systems/software.
  • Demonstrates conceptual, analytical and strategic thinking.
  • Effective at problem solving and conflict resolution.

  Why GSK?

  We offer:

  • Opportunity to join new department, participating in its development and constant improvement of ways of working.
  • Personalized learning approach (e.g. mentoring, online trainings’ platforms).
  • Wide offering of company benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, recognition awards for additional achievements, flexible working hours, company car)
  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)
  • Contract of employment - 18 months fix term

  #LI-GSK

  #LI-HYBRID

  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 positively impact the health of 2.5 billion people by the end of 2030.

  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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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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