Local Study Associate Director

Location: United Kingdom

Introduction to Role

Are you ready to lead country-level study delivery that accelerates breakthrough cancer therapies to patients? This role places you at the heart of pivotal clinical studies, turning strategy into execution with speed, precision, and purpose. You will translate bold decisions into real-world progress, guiding teams to deliver quality data on time and on budget—so patients feel the impact sooner.

You will lead local study teams with clear direction, strong governance, and a relentless focus on outcomes. Expect to shape site strategy, champion compliance, and remove barriers to recruitment and delivery. Can you see yourself orchestrating complex, multi-stakeholder studies while empowering others to perform at their best?

Accountabilities

• Country Study Leadership: Own end-to-end delivery of assigned studies at country level, ensuring timelines, quality, and budget are met, and data readiness is achieved to the required standards.
• Local Study Team Management: Lead and develop a high-performing team including Study Start-up Managers, Contract Managers, CRAs, and CSAs; set clear goals, drive accountability, and foster collaboration.
• Feasibility and Site Strategy: Oversee robust clinical and operational feasibility; identify and assess sites with appropriate risk evaluation; conduct or oversee site qualifications to ensure readiness and quality.
• Ethics and Regulatory Submissions: Ensure timely submissions to ethics committees and institutional review boards; partner with Regulatory Affairs on authority submissions throughout the study lifecycle in line with local requirements.
• Budget Stewardship: Prepare and manage the country financial Study Management Agreement; maintain accurate budgets and financial controls with regular system checks and reporting.
• Contracts and Informed Consent: Lead preparation of local Master Clinical Study Agreements, site budgets, and amendments; deliver country-level Master Informed Consent Forms and site-level ICFs, including translations, aligned to SOPs and local laws.
• Essential Documentation and Systems: Ensure collection and verification of trial essential documents prior to activation; set up and maintain studies in CTMS and any required local platforms; maintain accurate country-level records.
• Drug Supply Oversight: Plan and coordinate local investigational product activities from procurement or reimbursement through to destruction, ensuring full compliance.
• Monitoring Excellence: Oversee and coordinate monitoring from activation to close-out; review monitoring reports and provide proactive guidance; conduct co-monitoring and accompanied site visits to strengthen quality and consistency.
• Flexible Monitoring Support: Perform site monitoring as needed to support capacity and ensure continuity of study delivery.
• Risk Management and Issue Resolution: Develop and maintain country-level risk management plans; identify risks early, implement mitigations, and resolve complex issues swiftly.
• Recruitment Acceleration: Contribute to recruitment strategy, engage regularly with investigators, and deploy vendor solutions to remove barriers and meet enrollment targets.
• Stakeholder Engagement: Lead regular LST meetings and coordinate with local medical affairs and national investigators; communicate progress, risks, and mitigations to global counterparts, including study leadership and SMM leads.
• Forecasting and Resource Planning: Support forecasting of timelines, resources, recruitment, budgets, study materials, and drug supply to maintain study momentum.
• Business-Critical Systems and Compliance: Ensure systems supporting safety reporting, regulatory submissions, and clinical trial transparency are set up and maintained; manage accurate and timely site and vendor payments.
• Inspection Readiness: Maintain a complete, current, and inspection-ready eTMF; lead audit and inspection activities in partnership with quality functions; ensure timely final archiving.
• People Development and Coaching: Train and coach new team members; provide performance feedback on CRAs/CSAs to line managers; build a culture of continuous improvement.
• Process Improvement: Contribute to process enhancements and share site and investigator insights to inform future studies and local market understanding.
• Ethical Governance: Ensure all activities comply with company policies, SOPs, ICH-GCP, and local regulations, upholding the highest standards of integrity and patient safety.