Global Study Associate Director

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 to lead a cross-functional study team and provide 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 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 behaviours. 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 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.

Desirable:

• Advanced degree (Master's, Ph.D.)
• PMP certification

Work Environment:

• Office-based role requiring computer use, communications, problem-solving, and collaboration during standard business hours.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.