Data Lead

4 dni temu

Warszawa, Mazovia, Polska GSK Pełny etat

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.

  • 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.

#J-18808-Ljbffr

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