Associate Director, Study Delivery Lead

3 settimane fa

Siena, Italia GSK A tempo pieno

**Site Name**: Warsaw, Belgium-Wavre, Italy - Siena

**Posted Date**: Jan 13 2023

Study Delivery Lead - This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams.

**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.
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