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 Data Management (DM) study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.  

The role is located in Warsaw HUB office, where GSK can offer you the best flexible hybrid model of work – 2/3 days weekly from the office.
 

In this role you will be responsible:

• 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.

• 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 Data Management study related activities & matters.

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

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

• Creating or reviewing study level timelines for DM deliverables and ensures teams adhere to these

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

• Acting 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

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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

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

• Experienced in Clinical Data Management processes, standards, 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

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source

• Proficient in Microsoft excel and validation methodology

• Basic knowledge of PL SQL, SAS

Why GSK?

What we offer:

• Career at one of the leading global healthcare companies

• Contract of employment

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

• 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 counterparts

• Sports cards (Multisport)

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

• Personalized learning approach (mentoring, 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, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-Hybrid

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 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. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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