Centralized Monitoring Specialist
2 weeks ago
Critical Responsibilities:
- As a Centralized Monitoring Specialist, you will be responsible for ensuring the quality and integrity of clinical trials by implementing Risk-Based Quality Management aligned with study planning, protocols, GSK SOPs, ICH GCP, and regulatory requirements.
- You will drive discussions with Global Clinical Operations, Data Strategy and Management, Statistics and Programming, Medical and Safety teams to prevent study failure.
- Lead multifunctional teams to identify critical data and processes that provide robust risk assessment with management planning of appropriate mitigation strategies.
- Ensure monitoring mitigations to study and data risks are fit for purpose and included in operational plans.
- Utilize influencing skills and critical thinking to plan and execute studies.
- Accountable for study-level data analytics investigations, vendor deliverables, and performance.
- Develop and implement improvements to Central Monitoring and Data Analytics group and recommend tool enhancements to vendors.
- Assess and implement central monitoring requirements at a study level to ensure a consistent approach and oversight to data quality across multiple studies.
- Interpret the impact of analytic signals for study delivery during trial execution.
- Work with central monitors and study teams to define and agree on remediation to address trends, signals, and issues in the data.
- Subject matter expert (SME) on RBM, CMDA to the central study team and in-country operational staff, such as CRAs/SCRAs, Local Study Managers (LSMs)/Senior LSMs (LSSMs), and others aligned to their assigned study(studies).
- Mentor and train new central monitors, members of the central and local study teams on RBM, Centralized Monitoring processes, and applicable RBM Tool(s) using 70-20-10 learning principles.
Requirements:
- Minimum 1-3 years of clinical trial experience.
- RBM experience (minimum 1 year).
- Knowledge of quality, safety, risk management, and compliance (ICH and GCP).
- End-to-end clinical development experience.
- Understanding of RBM, Data Analytics, and Risk-Based Quality Management (RBQM) and their impact on data integrity.
- Business acumen demonstrated by understanding of risk management, problem-solving, and implications of decisions.
- A minimum of 1-3 years of central monitoring experience in drug development.
- Understanding of various local regulatory environments.
- Understanding and compliance with ICH GCP and applicable GSK Pharma R&D policies and SOPs.
About GSK:
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. We prevent and treat disease with vaccines, specialty, and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
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 place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
Important notice to Employment businesses/Agencies:
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
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