Sr. Project lead, Data Standards
GSK
Brentford, Middlesex
5d ago

Nombre del sítio : Belgium-Wavre, Bengaluru Luxor North Tower, GSK House, Mississauga, Stevenage, Warsaw

Fecha de publicación : Jun 17 2022

Job purpose :

This role is primarily responsible to create and maintain data standards and the supporting standard data flow.

Your responsibilities :

  • You support cross-functional teams and working groups to manage and improve the global data standards used across preclinical, clinical, and epidemiological studies.
  • The data standards include ePRO solutions for subject diaries, eCRFs with associated edit checks and form navigation scripts, underlying EDC (Electronic Data Capture) database structure, trial design metadata and CDISC SDTM package standards.

  • You set-up new data standards requirements and manage standardization activities.
  • You ensure alignment with other departments acting as primary point of contact for data standards within the organization.
  • You provide impact assessments and recommendations for data standards requests from Therapeutic Area project teams with a focus to accelerate development & process improvement.
  • You act as a member of the Data Standards related governance bodies and drive discussions on data standards.
  • You are responsible for effective governance of the GSK Therapeutic area database standards, and metadata standards.
  • You provide study data requirements for CDISC submissions and review study data set-up deliverables and study data submission packages.
  • You provide input for data standards related written standards (SOP (Standard Operating Procedures) and WIs (Work Instructions).
  • You perform and / or oversee system / database administration for the global Data Repository / Clinical Oracle database. This includes :
  • Operational and user support for the global Data Repository / Clinical Oracle database and the interfaces between the systems.

    Interact with IT (Information Technology), Clinical Systems team and the vendors that are hosting and / or supporting the applications.

    Maintain study data and system metadata in the global Data Repository / Clinical Oracle database and data ocean for CDISC studies.

    Maintain the global CDISC data standards database and associated central metadata and support development of CDISC standards.

    Maintain databases security / integrity.

    Why you?

    Basic Qualifications :

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

  • Bachelor’s Degree (or above) in engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
  • Minimum 2 years Clinical Research or Information Systems or relevant scientific experience and demonstrated good collaboration and communication skills
  • Minimum 3 years Clinical Research with experience in clinical database system administration.
  • Fluent English language (spoken and written)
  • Experienced in Clinical Data Management or Clinical Programming
  • Excellent computer skills, understands interfaces and data flow
  • Expert skill set for Clinical systems administration and security maintenance
  • Good programming skills required (e.g., SAS, SQL, Cognos), skills with other relevant tools are desired
  • Good understanding of clinical data and CDISC
  • Knowledge of CDISC standards (CDASH, SDTM, ADaM)
  • Strong understanding of regulations including ICH-GCP
  • Strong analytical skills
  • Effective communication and presentations skills, ability to facilitate interfaces within extended network, proven experience in negotiating and influencing at various levels of the organization in a matrix environment
  • Strong problem solving and project delivery skills
  • Able to build good working relationships virtually and face to face
  • Attention to detail, conscientious and accurate
  • Good organizational, planning and time management skills
  • Preferred qualifications :

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

  • Master’s Degree in engineering, Life Sciences, Computer Sciences, Mathematics and Physics
  • French language and Italian language known is a plus
  • Why GSK?

    At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution.

  • Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022 : New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science;
  • and a new world-leading consumer healthcare company of loved and trusted brands.

  • With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together all with the clear ambition of delivering human health impact;
  • stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

    Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture.

  • A culture that is ambitious for patients so we deliver what matters better and faster; accountable for impact with clear ownership of goals and support to succeed;
  • and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey.

    Join our challenge to get Ahead Together.

    Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo.

    Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble.

    Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

    Aviso importante a las empresas o agencias de empleo

    GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio.

    Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK.

    La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK.

    En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK.

    Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.

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