Clinical Operation Asset Lead

**Site Name**: Belgium-Wavre, Belgium-Rixensart, GSK House, Italy - Siena

**Posted Date**: May 19 2023
**Type of contract**: Permanent

**Location**: Belgium: Wavre, or Rixensart

United Kingdom: GSK House*

Italy (Siena)

**_ Join our challenge to get ahead of disease together_**:
**Your responsibilities**:
The Clinical Operations Lead (COAL) will be accountable for:
**Contribution to the development of the Clinical Development Plan and Integrated Evidence Plan, during Research, Development and LCM phases of the asset lifecycle**.
- Provides input into the overarching CDP and the development of studies that align to the Clinical development Plan (CDP) / IIntegrated Evidence Plan (IEP) and are feasible to implement in the clinical and regulatory environment of participating regions, to provide quality data and ensure timely study delivery, coordinating expert inputs from clinical and non-clinical functions.
- Utilises lessons learnt and prior experiences to ensure best practises and strategies.
- Be part of the protocol finalisation and relevant review boards/committees to ensure operational feasibility and consistency within the asset.

**Resourcing strategy**
- Leads resourcing discussions accountable on final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.
- Approves/endorses assessment, selection, and management of appropriate vendors for outsourced clinical activities and services, ensuring compliance with GSK standards.

**Oversight of delivery quality**
- Lead escalation point from study and asset level to raise and assist with issues on behalf of the team, including serious quality incidents and serious breaches of GCP.
- Responsible for the coordination and leadership of cross-functional team input into development plans, ensuring quality delivery of all studies included within the plans.
- Ensure regular interaction with Global Clinical Delivery (GCD) functions involved in the asset such that they are aware of issues, risks, and successes with study delivery as they occur.
- For outsourced programs coordinate oversight to ensure the quality delivery by Full Study Outsourcing (FSO) provider.

**Delivery plan**
- Model scenarios for optimal asset/study delivery linked to value drivers and drives decisions presented to governance boards to optimise delivery with transparent implications to time, quality, risks resources and budget.
- Accountable for the operational planning, feasibility and delivery of their assigned asset(s) and associated Development Plan(s), on time and on budget, from beginning to end whilst optimizing time and cost efficiency, including resource utilization.
- Drives innovative approaches to study delivery through external facing advances in technology and sciences, by identifying and embracing risks and opportunity
- Accountability for asset delivery strategy (e.g., country, diversity, patient engagement strategies etc) in collaboration with cross-functional stakeholders, with accountability for Clinical Operations contributions to governance boards
- Accountability for budget forecasts for future interventional clinical and Epi studies and Clinical Operations asset level costs, ensuring they are accurately represented and managed in financial tools
- To ensure clinical operational delivery with a collaborative partner in a co-development environment
- Part of the clinical file submission team coordinating deliveries linked to interventional clinical and Epi studies and responses to questions raised by Health Authorities on operational activities. Responsible to deliver applicable operational modules for the file.

**Asset level risk register, communication, and systems data**
- Ensure asset level operational risk management plan is in-place and applies a smart-risk taking philosophy
- Accountable for asset level mitigation plans are implemented to avoid and manage risk/quality issues
- Accountable for translating the technical content of the TMP/TVP/IEP to ensure appropriate implementation at the study level
- Manages internal and external stakeholders through appropriate engagement and communication
- Accountable for all data related to delivery strategy (e.g., country footprint, resourcing strategy) is accurate and contemporaneous in GSK systems (including clinical trial tracking systems).

**_ Why you?_**

**Basic Qualifications**:

- Demonstrates conceptual, analytical, and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability
- Ability to translate strategic concepts, scientific requirements, stakeholder feedback and requirements into cohesive actions for the Asset team
- Ability to define value-driven vision and roadmap for the Clinical and or Epi Development Plan
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, showing conflict management and