Data Management Quality Lead
GSKThe Data Lead is responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.
Key Responsibilities:
Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include: o Electronic Case Report Form, vendor data, and other clinical outcome assessments o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation o Interim and final cleaned database lock o Archival of all DM documents in the eTMF o Archival of the study database and provision of clinical data to the study site.
For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study core 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 Develops and maintains excellent professional relationships with study team and other key stakeholders.
Why You?
Basic Qualification:
Fluent in written and spoken English.
Detail‑oriented and organized with proven ability to prioritise, multi‑task and manage time effectively.
Excellent interpersonal and teamwork skills; adaptable and agile mindset; willing to work in a global environment.
Problem‑solving mindset, quick learner, results‑oriented and customer‑focused.
Experience in Clinical Data Management processes, standards and clinical systems.
Hands‑on exposure to EDC/eSource platforms (InForm, Medidata Rave, Veeva/OC), e‑diaries (added advantage).
Understanding of general data flow, database architecture and clinical database design concepts.
Good understanding of regulations: ICH‑GCP, 21 CFR Part 11 and CDISC requirements.
Proficient in Microsoft Excel and familiar with validation methodology.
Basic knowledge of PL/SQL/SAS and medical terminology; CCDM certification is an advantage.
Working model
This role is hybrid. You will be expected to work from our Poland office regularly and be available for in-person collaboration.
Why GSK?
Career at one of the leading global healthcare companies.
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: Pluralsight, 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 everyday.
Free car and bike parking, locker rooms and showers.
#LI-GSK #LI-Hybrid
The annual base salary in Poland for new hires in this position ranges from PLN 186,750 to PLN 311,250 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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