Associate Director Senior Study Lead - Single Sponsor Dedicated (Home-Based)

About the role

The Associate Director Senior Study Lead leads a cross-functional clinical trial team (CTT) and guides planning and management of an assigned clinical study or studies end to end, achieving its objectives. The role is home-based and focuses on a single sponsor dedicated study. It is not eligible for UK visa sponsorship, and only candidates based in the listed location are considered.

Key responsibilities

• Execute and deliver clinical studies, guiding planning and decision-making at study level
• Act as the CTT product owner with clear duties under agile ways of working
• Contribute to operational excellence by improving processes and sharing knowledge across studies
• Promote excellence in the development of global clinical study protocols, clinical study reports and other study documents
• Manage the study budget and allocate resources effectively
• Deliver patient recruitment, clinical data, study documentation and reports, delivering the protocol, informed consent form, monitoring plan and CSR in quality and on time
• Apply proactive, iterative operational planning with contingencies and an embedded risk management mindset

Required profile

• Bachelor's degree in life sciences, healthcare or a clinically relevant field; advanced degree strongly preferred
• At least 4 years of recent involvement in clinical research or drug development (Phases I through IV) in an academic or industry setting
• At least 3 years of experience conducting clinical studies of standard to high complexity in a global, matrix environment, in pharma or a CRO
• Expert knowledge of GCP/ICH, FDA/EMA and national health authorities
• Experience managing people globally and leading virtual teams; experience with internal and external stakeholders
• Fluent English, oral and written

Required skills

• Excellent communication and presentation skills at all levels
• Organization, prioritization, negotiation and conflict resolution
• Enterprise mindset and ability to drive aligned solutions