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Job Details


GlaxoSmithKline (GSK)

Senior Study Delivery Lead

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw
Posted Date: Jan 17 2022

GSK is looking for a Senior Study Delivery Lead to join our ever-growing Clin Ops team in Poland. You will be accountable for the execution and delivery of complex studies. You will develop and follow the most efficient operating model for collaborative studies, and you will manage risks linked to supported/collaborative studies. Moreover, as the Senior Study Delivery Lead, you will manage multidisciplinary teams (up to 30 team members). This is a fantastic opportunity for anyone who is looking for a senior position in clin ops!

Key responsibilities:

  • Accountable and responsible for delivery of study as defined by protocol and according to agreed timelines and budget set in the Development Plan (Clinical, Epidemiology development plans, including local studies):

    • Define study operational model
    • Lead clinical and non-clinical functions to ensure study delivery and take operational decision at study level (will refer to Project Delivery Lead as needed)
    • Develops study plan and forecast, including detailed schedule and budget
    • Develop and maintain Study Risks management plan
    • Define resource requirements and ensure appropriate resourcing (including outsourcing)
    • Tracks delivery to time, cost and quality, including maintenance of standard tools such as iPlan, eTrack and SAP
    • Prepare study management, monitoring and communication plans (including definition of study essential data for adaptive monitoring)
    • Ensure appropriate study oversight including study kick off meeting(s), regular TC with LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up actions are taken
    • Set up of dashboard, regular review of trial monitoring tools (TMTs), key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports / tools
    • Establishes study performance reporting tools and communicates progress to Project Delivery Lead and study team
  • Leads and oversees operational activities in study design and study execution including

    • Inputs to concept protocol and protocol development to ensure optimal operational design and feasibility, and co-ordinates study execution plan health check
    • Accountable for study feasibility
    • Participates in country and site selection, with reference to pre-selection decisions made at Development Plans level
    • Ensures appropriate training of country staff and sites on protocol and project specific matters - Prepare/deliver Investigators/monitors meeting (when applicable)
    • Develops and ensures on-time execution of supportive documents, plans and manuals including the study management and monitoring plan, study procedures manuals, data quality plan, core operational packages for submission and for countries
    • Ensures functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality
    • Ensuring that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements
    • Responsible for vendor management activities including selection and contract development
    • Responsible for Study-level oversight, communications and issue management
    • Provides input to the clinical study report / module appendix
    • Sign-off essential study documents
    • Ensure appropriate documentation of Oversight is available in the TMF at all times, ensure completion of Trial Master File (collect of Essentials doc…), ensure archiving for paper file
    • Ensure collection and review of Protocol deviations and ensure review & analysis of Data Quality Escalate as appropriate.
  • Project manages study activities including

    • In partnership with the Clinical Research Development Lead (CRDL), Epidemiologist , Country Medical Directors (for local studies), co-ordinates all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time
    • Manages study communications and issue escalation within the team, and communicates progress and escalates issues to the Project Delivery Lead when appropriate
    • Ensure all systems are correctly populated and up to date
  • Ensures the study is delivered with quality, in accordance with ICH/GCP and regulatory requirements

    • Ensure development and management of the Study Quality Management Plan and conduct related quality assessment, endorse proposal for site assessments/audits, analyse and follow up assessment reports
    • Ensure a study-level risk assessment is performed and identified risks are appropriately mitigated
    • Ensure issues escalation and management up to resolution
  • Typically responsible for >4 trials of average to very high design and protocol complexity

  • Develops and follows the most efficient operating model for collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements – Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management) as the sSDL has full credibility vis a vis external partners and 3rd parties.

  • As part of his/her development, the sSDL may contribute to a small clinical development sub-program operational strategy and takes the oversight of its delivery

  • Maintains expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the SDL team and beyond.

Basic Qualifications:

  • University Scientific Degree

  • Significant experience in managing complex clinical research studies, clinical operations or equivalent

  • Strong skills and experience in project management and tools

  • Excellent communication and presentation skills

  • Solid experience working in teams with a broad range of cultures, including team leadership

  • Demonstrates an excellent understanding of the clinical study, drug development , sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs

  • Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

Preferred Qualifications:

  • Master, Post graduate degree in a life science field desirable

  • In-country CRA / monitoring/ sites experience an asset

*LI-GSK

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