Location : Barcelona, Spain (On-site) 3 days working from the office.
The Global Study Associate Director (GSAD) is a business-critical role whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team and providing the team with direction and guidance to enable successful study delivery. The GSAD is accountable to the GPT for the delivery of a study according to agreed-upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within the study team and / or external partners. The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and / or clinical outsourcing model, current clinical trial regulations (e.g., ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g., job aides, guidelines), and in line with Alexion’s mission, values, and behaviors. Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).
Role Overview :
* Deliver clinical studies with accountability for timelines, budget, and quality.
* Lead a cross-functional team following the Rare Disease Study Team Operating Model (rSOLID) and applicable regulations.
* Manage studies across various phases and therapeutic areas.
Key Responsibilities :
* Direct and coordinate cross-functional study teams to achieve milestones.
* Develop and maintain study documents and plans.
* Facilitate communication and support study team members.
* Serve as the main contact for the Clinical Trial Team (CTT), Global Project Team (GPT), and Clinical Sub-Team (CST).
* Monitor study performance, manage risks, and ensure inspection readiness.
* For outsourced studies, oversee vendor performance and maintain oversight.
* Manage global clinical operations budget and forecasts.
* Conduct lessons learned for continuous improvement.
* Collaborate on country and site feasibility and study design.
* Mitigate risks related to site management and monitoring.
Qualifications :
* Clinical research experience, 2 years in a leading role for global trials.
* Bachelor's degree in a relevant field or equivalent experience.
* Strong knowledge of regulatory requirements and study management.
* Demonstrated leadership and communication skills.
* Advanced degree (Master's, Ph.D.)
* PMP certification
* Office-based role requiring computer use, communications, problem-solving, and collaboration during standard business hours.
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