Local Study Associate Director

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.