Global Study Lead

About the position

The position involves leading global study teams with full accountability for study deliverables, ensuring high-quality study designs, and managing the operational aspects of clinical trials. The role requires collaboration with various stakeholders to support global strategies and adherence to regulations, while also overseeing the budget and timelines for assigned studies. This is a remote-based role focused on delivering compliant evidence to enhance patient care.

Responsibilities

• Lead the global study team with accountability for study deliverables regarding quality, budget, and timelines.
• Collaborate with internal and external experts to develop high-quality study designs for sponsored studies.
• Prepare different scenarios for evidence generation in collaboration with Program Leadership and cross-functional teams.
• Develop key study documents including Design Validation Plan, protocol, training materials, forms, and reports.
• Oversee planning and operational aspects of companion diagnostics studies sponsored by Pharma partners.
• Ensure adherence to regulations, guidelines, and standard operating procedures, maintaining audit readiness.
• Execute sponsored studies through all phases including planning, start-up, conduct, and close-out.
• Oversee study activities outsourced to service providers (CROs).
• Ensure publication of study results in collaboration with the Publication Team.
• Track project performance to analyze completion of short and long-term goals.
• Build and maintain relationships with cross-functional leaders, stakeholders, and alliance partners.

Requirements

• At least 5 years of experience in clinical trial management or related field.
• Bachelor's degree in Life Science or relevant expertise in the Healthcare Industry.
• Knowledge and experience in oversight and conduct of clinical trials within core laboratory or serology diagnostics.
• Conceptual and practical knowledge of Product Development and Clinical Operations.

Nice-to-haves

• Experience in multiple disease areas.
• Background in Personalized Healthcare Solutions (PHCS)/Companion Diagnostic studies.
• Knowledge of pathology/tissue diagnostics indication areas.
• Ability to lead moderate-sized projects and provide functional guidance to colleagues.

Benefits

• Discretionary annual bonus based on individual and company performance.