The purpose of the role is to lead the implementation of Risk Based Quality Management (RBQM) across studies, focus on Centralized Monitoring (CM) and Data analytics (DA) to ensure consistent application of RBQM principles. Accountable for setting up and execution of CM with DA to enable timely quality study delivery.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Single point of accountability to embed the application of Risk Based Quality Management aligned with the study planning, study protocols, GSK SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored and outsourced studies.; includes the set up and execution of Central Monitoring and Data Analytics tool

• Drive discussions with Global Clinical Operations, Data Strategy and Management, Stats and Programming, Medical and Safety team at CSI for critical to quality measures to prevent study failure

• Initiate and lead multifunctional teams on identification of critical processes that enable 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 the appropriate operational plans (e.g. Monitoring Plan, Central Monitoring Plan and QTL Report)

• Accountable for study level data analytics investigations, vendor deliverables and performance

• Assess and implement central monitoring requirements at a study level to ensure consistent approach and oversight to data quality to multiple studies

• Interpret analytic signals' impact during trial execution

• Work with central monitors and study teams to address data trends, signals and issues

• Subject matter expert (SME) on RbQM and Centralized Monitoring to the central and local study teams.

• Mentor and train new CMDA members, members of the central and local study teams on RbQM, Centralized Monitoring processes and applicable RbQM Tool(s) using 70-20-10 learning principles

Why You?

Working arrangement

This role is hybrid. You will be expected to work regularly from our office and collaborate with international colleagues.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• A minimum of 1-3 years’ central monitoring experience in drug development

• Experience with RBQM tools and data analytics and understanding their impact on data integrity.

• End-to-end clinical development experience

• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)

• A good understanding of graphics, visuals and ability to interpret story behind the data

• Fluent English (speaking and writing)

• Excellent communication/influencing and analytical skills

• Understanding and compliance with ICH GCP, and applicable GSK R&D policies and SOPs.

What we offer:

• Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.

• Established job in an international, well-known pharmaceutical company.

• Opportunity to work in professional team plays crucial role in maintaining GSK portfolio on the markets.

• Opportunity to work within GSK standards and documentation applied globally.

• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).

• Supportive & friendly working environment.

We’re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we’d love to hear from you!

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The annual base salary in Poland for new hires in this position ranges from PLN 320,250 to PLN 533,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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