• Job Description

  Req#: 379692

  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.
  
  

  DATA LEAD

  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

  • 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 (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

  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.

  If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

  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.

  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. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

  Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

Notice