Associate Site Activation Director

Job Overview

The Associate Site Activation Director is responsible for leading the strategic, operational, and financial delivery of site activation activities across assigned clinical programs, regions, and customer engagements. This role provides leadership and oversight for site identification and selection, regulatory and ethics approvals, site contracting, and activation activities to ensure studies are initiated efficiently, compliantly, and in alignment with customer expectations. The Associate Director serves as a senior subject matter expert and strategic partner to sponsors, project leadership, and Site Activation teams, driving operational excellence, customer satisfaction, and continuous improvement initiatives across the clinical trial startup lifecycle. This position plays a critical role in accelerating study startup timelines, advancing enrollment readiness, and ensuring successful delivery of complex global clinical programs.

Essential Functions

Strategic Site Activation Leadership

• Provide strategic leadership for the planning, execution, and oversight of global and regional site activation activities, ensuring delivery against timeline, quality, budget, and customer expectations.
• Lead site activation strategy development from pre-award through site activation and lifecycle maintenance, identifying opportunities to accelerate startup performance and reduce study activation timelines.
• Oversee study startup delivery across one or more regions comprising multiple countries, ensuring alignment with project scope, customer requirements, and operational objectives.
• Serve as a senior escalation point for complex startup challenges, providing strategic solutions and driving issue resolution.
• Partner with global study teams to proactively identify risks, assess impact, and implement mitigation plans to support successful project delivery.

Operational Delivery & Study Execution

• Develop, implement, and oversee Site Activation Management Plans aligned with project strategy, Scope of Work, and contractual commitments.
• Ensure execution of startup activities in compliance with ICH-GCP, applicable regulatory requirements, study protocols, sponsor expectations, and company quality standards.
• Drive operational excellence through effective oversight of study approvals, regulatory submissions, ethics review processes, contract negotiations, and essential document management.
• Monitor project performance through established metrics, timelines, key performance indicators, and financial measures to ensure successful delivery.
• Ensure accurate maintenance of startup systems, databases, forecasting tools, project plans, and reporting platforms.

Regulatory Strategy & Risk Management

• Provide strategic guidance on regulatory pathways, submission requirements, ethics approvals, and country-specific startup requirements.
• Evaluate evolving regulatory landscapes and leverage regulatory intelligence to optimize startup strategies and execution plans.
• Identify regulatory complexities an...

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