Senior Study Data Management Quality Leader

We are looking for experienced and dynamic Senior Study Data Management Quality Leader (Sr DMQL) who will be part of the Data Management group within our constantly growing GSK R&D Polish Hub. This role is focused on expert oversight on DM deliverables and strong E2E leadership together with CRO vendor management component. 

Role location: Warsaw HUB office, where GSK can offer you the best flexible hybrid model of work – both home and office based. 

Responsibilities:  

• Oversight of end-to-end Data Strategy and Management (DS&M) for one or several complex studies, delivered by DM Functional Service Provider (FSP) or Full Service Outsourced (FSO) studies to the agreed quality, timelines and budget

• Study level contribution, working in close collaboration with other key members of the internal and external study team

• Point of contact for data management and data quality considerations for GSK and CRO stakeholders

• Providing input to protocol and other GSK plans, e.g., Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management Plan (or equivalent), during the planning phase

• Oversight of in-stream data flow activities, with accountability for clean database delivery in accordance with the Data Management Plan or equivalent

• Provides expert opinion into the electronic and external data capture tools design, including eCRF, eCOA, etc

• Managing vendor performance against study-specific Service Level Agreements. 

• Acts as mentor and SME for DS&M team

Why You? 

What skills and expertise you will bring to the role: 

• Relevant education degree from Scientific Discipline (Biomedical or Computer)

• Min. 5 years of data management/clinical trials experience in Pharma, CRO and/or ARO 

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

• Fluent English, both spoken and written

• Good communication skills, verbal and written, ability to effectively communicate and maintain strong working relationships in global teams at all levels of the organization

• Demonstrated project management ability to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets

• Understanding of laboratory data including biomarker data

• Experience of InForm, RAVE and/or Veeva EDC systems will be an advantage

• Experience working with key global preferred suppliers/ partnerships, to ensure deliverables are to the agreed standard

 Why GSK?

At GSK we offer a wide range of additional benefits: 

• Career at one of the leading global healthcare companies

• Hybrid work ( 2/3 days per week from the office)

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities). 

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

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Why Us?

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 organization 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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