Data Lead

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D

Data Lead

We are looking for quickly learning, open minded and independent Data Lead who will be a part of the Data Management group within our constantly growing GSK R&D Polish Hub. This role is responsible for overseeing the end-to-end DM study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.

Data Lead role is located in Warsaw HUB office, where GSK can offer you the best flexible hybrid model of work – both home and office based.

Responsibilities

• For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study team and is the single point of contact for all the DM study related activities & matters

• For study outsourced through a DM Functional Service Provider (FSP), conducts & documents DM sponsor oversight of the end-to-end FSP study related activities and ensures training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies.

• Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register

• Provides reports, status updates, feedback and advice to key study stakeholders on study progress

• Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these

• Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity

• Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level

• Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines  

Why You?

What skills and expertise you will bring to the role:

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

• Experienced in Clinical Data Management processes, standards and clinical systems and Project Management

• Fluent in written and spoken English

• Understanding of general data flow & database architecture concepts

• Good understanding of clinical drug development process and regulations including ICH-GCP, 21 CRF part 11, CDISC requirement

• Proven ability to prioritize and multi-task, along with effective time management skills

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

• Excellent interpersonal and teamwork skills

• Demonstrates adaptability and an agile mindset

• Result-driven, proactive, detail-oriented, problem solver.

• Willing to work in a Global environment

Other advantages:

• Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage

• Proficient in Microsoft excel and validation methodology

• Basic knowledge of PL SQL, SAS is an added advantage

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 playing 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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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- to discuss your needs.

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- 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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