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Job Details


GlaxoSmithKline (GSK)

Principal Project Lead, Data Standards

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw, Poznan Business Garden
Posted Date: Mar 9 2022

Principal Project Lead, Data Standards and SDTM Delivery
This role is primarily responsible to lead cross-functional teams to maintain and improve the global data standards ensuring standard innovation, compliance and strategic alignment with Standard Governance. Ensures data standards are of top industry and scientific quality for pipeline delivery. This role mentors other DS&M team member(s) and acts as Subject Matter Expert.

Key Responsibilities

  • Lead cross-functional teams and working groups to manage and improve the global data standards used for pipeline delivery that includes CDASH, SDTM, Controlled Terminology and Value Level Metadata, and the source data to SDTM mappings
  • Act as a primary point of contact for data standards within the organization and ensure strategic alignment with Standard Governance
  • Provides impact assessments and recommendations for non-Standard requests and Standard updates
  • Guide study teams and lead discussion on study specific deviations from Standard
  • Responsible for effective governance and project delivery of the GSK end-to-end Standards
  • Maintain the Standards templates and supporting documents (e.g. Define.xml, Reviewers Guide) for CDISC submissions in collaboration with the stakeholders
  • Contributes to development of Standards related process documentation, e.g., SOPs, Working Instructions, Best Practice, Template etc
  • May act as Subject Matter Experts in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
  • Acts as a mentor for junior members of the Data Standards team

What skills and expertise you will bring to the role:

  • Bachelor’s Degree in Sciences ( Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent ) or equivalent functional industry experience
  • Minimum 5 years in Clinical Research with experience in managing CDISC compliant Data Standards
  • Good analytical, project management and communication skills (fluent English, spoken and written)
  • Proven experience in negotiating and influencing at different levels of the organization in a matrix environment
  • Experienced in leading improvement initiatives from inception through to completion involving both multi-disciplinary and geographically remote partners
  • Excellent knowledge of industry standards & regulations:
    • ICH-GCP
    • CDISC CDASH, SDTM, ADaM,
    • Regulatory requirements on data submissions
  • Experienced in Clinical Data Management and/or Clinical Programming
  • Excellent computer skills, understands interfaces and data flow are preferrable e.g. Expert skill set for Clinical systems administration and security maintenance

At GSK we offer a wide range of additional benefits:

  • 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 (internal trainings, mentoring, access to 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, short Fridays option, health & well-being activities).
  • Supportive community and integration events.
  • Modern office with creative rooms, fresh fruits every day.

*LI-GSK

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