Description
The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine is a group of scientific operations professionals who turn clinical diagnostic strategy into reality across early and late-stage oncology trials. As Diagnostic Delivery Lead, you will own the operational delivery of diagnostics within your assigned studies: from biosample collection and clinical trial assays at reference and central laboratories, to data that is ready for analysis, always audit-ready.
Responsibilities:
- Implement clinical diagnostic plans for oncology programmes in early and late-stage development, ensuring audit readiness at all times, and identify, document and manage project risks.
- Define and deliver biosample collection, processing and storage for your studies, ensuring logistical feasibility and cost-effectiveness, and forecast and manage biosample analysis and sample management costs.
- Manage the implementation of clinical trial assays at reference labs, central labs and CROs, including contract execution and vendor oversight, and act as the key contact for assay laboratories.
- Provide diagnostic input to protocols, informed consent forms and other study documents; work with Clinical Operations on site communications and training materials, and train CRO and internal teams on sample collection and processing.
- Align with Data Management and Biostatistics on data requirements, contribute to data transfer agreements and ensure data is ready for analysis; act as first point of contact for biosample operational questions, resolving or escalating issues and providing regular status updates, including sample tracking reports.
- Drive process and system improvements, coach and mentor colleagues as a subject matter expert, and role-model GSK values.
Basic Qualifications:
- Bachelor’s degree in life sciences, biomedical science, or a related discipline.
- Experience in project or delivery management within diagnostics, clinical development, or healthcare settings.
- Knowledge of diagnostic technologies and their application in clinical trials or healthcare delivery.
- Understanding of regulatory requirements and quality standards relevant to diagnostics.
- Strong organisational and communication skills with the ability to engage diverse teams and partners.
- Ability to manage multiple priorities and navigate a fast-paced, matrix working environment.
Preferred Qualifications:
- Master’s degree or higher in a relevant scientific or healthcare discipline.
- Experience working within pharmaceutical or biotechnology companies, especially in diagnostic or clinical operations roles.
- Familiarity with advanced diagnostic technologies or biomarker development.
- Experience managing vendor relationships and contracts.
- Demonstrated ability to contribute to process improvements and implement best practices.
- A collaborative and proactive approach to problem-solving and stakeholder engagement.
The role offers a hybrid working model, combining remote work with on-site collaboration.
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