Role Overview This role provides strategic, operational, and technical leadership for clinical trial laboratory and diagnostic activities.
Responsibilities span planning, execution, vendor oversight, data quality, and cross-functional collaboration to ensure clinical trials are delivered on time, within budget, and in compliance with regulatory and quality requirements.
Job responsibilities may evolve over time to meet business and project needs.
Key Responsibilities
1. Portfolio Strategy, Planning & Delivery Provide end-to-end oversight of clinical laboratory, ECG, imaging, sample storage, and diagnostic services for assigned clinical trials.
Act as a subject matter expert for laboratory and diagnostic biomarkers, including assay development and validation considerations.
Offer technical and logistical guidance on laboratory and diagnostic strategies to support study objectives.
Review and contribute to clinical protocols to ensure laboratory and diagnostic requirements are appropriately defined.
Develop and oversee clinical testing strategies, laboratory management plans, and study risk oversight related to diagnostic data.
Collaborate with sourcing and procurement teams to support vendor selection and sourcing strategies.
2. Project & Operational Management Proactively identify, monitor, and escalate risks, issues, and trends to senior stakeholders as required.
Drive data completeness, accuracy, and quality for clinical laboratory data within business systems.
Lead effective cross-functional communication to manage timelines, milestones, dependencies, and decision points.
Clearly articulate the value of laboratory and diagnostic solutions in terms of quality, cost, timelines, reliability, and scalability.
Monitor trial budgets and ensure compliance with internal financial governance processes.
Maintain accurate laboratory testing scope, budget data, and study information within laboratory and diagnostic tracking tools.
Ensure ongoing inspection readiness, including maintenance of a complete and accurate trial-level eTMF.
Provide regular updates to study teams on trial metrics, performance, and emerging issues.
3. People & Capability Development Actively participate in performance management and development processes.
Model organisational values and behaviours, promoting collaboration, integrity, and accountability.
Provide peer coaching and knowledge sharing, fostering a culture of inclusion, innovation, continuous improvement, and external awareness.
Minimum Qualifications Bachelor's degree in a science or related life-sciences discipline.
Preferred Experience & Skills Knowledge of clinical drug development and clinical trial operations.
Prior laboratory experience or strong understanding of laboratory testing.
Excellent self-management, organisational, and prioritisation skills.
Strong communication skills (written and verbal) with the ability to engage cross-functional stakeholders.
Proven teamwork and interpersonal skills.
Conceptual understanding of information technology and clinical systems.
Strong attention to detail and problem-solving capability.
Negotiation and vendor-management skills.
Clinical trial experience preferred.