Remote Lead Clinical Study Manager - Strategy & Execution

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to drive study strategy and execution remotely from the U.S. The role oversees cross-functional teams, ensures ICH-GCP compliance, and partners with CROs to meet timelines and budgets.

The ideal candidate has 6+ years in pharma/ CRO with global trial experience and an advanced degree preferred. Strong communication, leadership and problem-solving skills are essential to lead complex studies and ensure quality outcomes.

Qualifications

• BS/BA in health-related or life science field; advanced degrees may supplement experience.
• 6+ years in pharma/ CRO with clinical study management experience.
• Experience in global/international trials and multiple therapeutic areas.

Responsibilities

• Plan and oversee operational strategy and execution for clinical trials within budget and timelines.
• Provide SME input into protocol synopsis, final protocol and study documents.
• Oversee budgets, enrollment, and gaiting; manage vendors and third-party CROs.
• Lead vendor selection, contract negotiation and performance oversight.
• Ensure inspection readiness and regulatory compliance throughout studies.

Skills

Communication skills

Teamwork

Organizational skills

Interpersonal skills

Problem-solving

Fluent English

Education

BS/BA in health-related field

Advanced degree (MS/PhD)

Job description

Takeda is seeking a Lead Clinical Study Manager to drive study strategy and execution remotely from the U.S. The role oversees cross-functional teams, ensures ICH-GCP compliance, and partners with CROs to meet timelines and budgets.

The ideal candidate has 6+ years in pharma/ CRO with global trial experience and an advanced degree preferred. Strong communication, leadership and problem-solving skills are essential to lead complex studies and ensure quality outcomes.