Senior Clinical Study Lead - Remote

Takeda; Agawam (MA); Hybrid; USD 116,000 - 182,000; Full time

Benefits offered by this job

Remote work

Job summary

Takeda in Massachusetts — Virtual is seeking a Lead Clinical Study Manager to drive study operations across assigned programs, reporting to the Clinical Operations Leadership team. This remote role emphasizes strategic planning, quality, and budget adherence while coordinating with CROs and vendors to keep studies on track.

You will oversee budgets, timelines, feasibility, and regulatory readiness, mentoring junior CSMs and supporting global study execution to Takeda standards.

Qualifications

• BS/BA in health-related or life sciences field; advanced degree may supplement experience.
• 6+ years in pharma/ CRO with 4+ years clinical study management/oversight.
• Experience in global/international studies; multiple indications advantageous.
• Knowledge of US CFR, EU CTD, ICH GCP; local country requirements.

Responsibilities

• Lead study operational strategy and planning for assigned clinical program(s).
• Oversee CROs/3rd party vendors to meet ICH-GCP and Takeda objectives.
• Manage study budgets, timelines, and enrollment; ensure feasibility across sites.
• Provide onboarding and mentoring for junior Clinical Study Managers.

Skills

Project management

Leadership

Communication

Teamwork

Fluent English

Education

BS/BA in health-related field

Advanced degree (MS/PhD)

Job description

Takeda in Massachusetts — Virtual is seeking a Lead Clinical Study Manager to drive study operations across assigned programs, reporting to the Clinical Operations Leadership team. This remote role emphasizes strategic planning, quality, and budget adherence while coordinating with CROs and vendors to keep studies on track.

You will oversee budgets, timelines, feasibility, and regulatory readiness, mentoring junior CSMs and supporting global study execution to Takeda standards.