Study Start Up Lead

Roche

Your responsibilities

Strategic Country Leadership: You will spearhead the national study start-up strategy, ensuring all operations align with global timelines while driving local efficiency and innovation.

Operational Excellence & Compliance: You ll oversee the end-to-end start-up lifecycle from site activation and regulatory submissions to managing complex amendments guaranteeing strict adherence to compliance standards.

Process Innovation & Automation: You will act as a change agent by identifying opportunities for standardization and automation, collaborating with global counterparts to harmonize systems and accelerate delivery timelines.

High-Level Regulatory Advocacy: By engaging directly with Health Authorities, Ethics Boards, and government bodies, you will influence clinical trial policies and optimize the local regulatory environment.

Disease Area (DA) & Site Strategy: You will develop the country-level Site Engagement strategy, aligning clinical priorities with local market maturity and making data-driven investment decisions regarding Principal Investigators and sites.

Strategic Site Intelligence: During the landscaping and setup phases, you ll provide expert insights into protocol feasibility and site suitability to ensure rapid recruitment and high-quality study settings.

Relationship Management & Escalation: You will serve as the primary local escalation point for operational challenges and build deep, long-term partnerships with diverse site stakeholders, including clinic administration and pharmacy leads.