Senior Clinical Study Lead – Global Trials, Remote

Takeda; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to oversee clinical trial strategy and execution across development programs. This role ensures studies comply with ICH GCP and regulatory standards, stay on schedule, and meet budgets.

Responsibilities include trial planning, vendor management, protocol collaboration, site selection, budget control, and regulatory inspection readiness, with mentoring of junior staff and involvement in initiatives.

Qualifications

• 6+ years' experience in pharma or CRO with clinical study management experience.
• Exposure to early phase or Phase 2/3/global studies.
• Knowledge of global regulatory standards (US CFR, EU CTD, ICH GCP).
• Skills in project management, stakeholder communication, and team leadership.

Responsibilities

• Oversee clinical trial strategy and execution within development programs.
• Ensure studies meet quality standards, timelines, and budgets.
• Operational oversight of trials and vendor management.
• Collaborate on protocol development, feasibility, and site selection.
• Budget management and vendor negotiations; risk mitigation.
• Regulatory inspection readiness; mentor junior staff; participate in initiatives.

Education

BS/BA in life sciences or related field

Advanced degree(s) in related field

Job description

Takeda is seeking a Lead Clinical Study Manager to oversee clinical trial strategy and execution across development programs. This role ensures studies comply with ICH GCP and regulatory standards, stay on schedule, and meet budgets.

Responsibilities include trial planning, vendor management, protocol collaboration, site selection, budget control, and regulatory inspection readiness, with mentoring of junior staff and involvement in initiatives.