Project Manager (FSP), Remote (US)

Thermo Fisher Scientific • OH

108d

About The Position

The Clinical Study Manager (CSM) at Takeda is responsible for leading or supporting the operational strategy and planning of clinical studies. This role involves overseeing the execution of select clinical studies, ensuring compliance with quality standards, and managing relationships with strategic partners and vendors. The CSM will work closely with the Clinical Operations Program Lead and Clinical Operations Manager to ensure studies are conducted on schedule and within budget. The position requires a strong background in project management, vendor management, and clinical study oversight.

Requirements

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• 5+ years’ experience in the pharmaceutical industry or clinical research organization.
• 3+ years of clinical study management/oversight experience.
• Knowledge of global regulatory and compliance requirements for clinical research.
• Demonstrated experience in project/program management and matrix leadership.
• Fluent business English (oral and written).
• Strong organizational, communication, and problem-solving skills.

Nice To Haves

• Advanced degree(s) such as a Master's or Doctorate.
• Experience in more than one therapeutic area.
• Experience with early phase clinical studies or Phase 2 and 3 studies.

Responsibilities

• Lead or support study operational strategy and planning for assigned clinical programs.
• Oversee execution of clinical studies in compliance with quality standards.
• Manage relationships with Strategic Partners and CROs to meet obligations.
• Accountable for planning and operational strategy for assigned clinical trials.
• Provide subject matter expertise and operational input into study documents.
• Participate in country and site feasibility/selection processes.
• Develop and manage study timelines.
• Identify and oversee trial risks and mitigation strategies.
• Lead cross-functional study teams.
• Support budget development and management.
• Conduct oversight monitoring visits and review key monitoring documents.
• Ensure studies are inspection ready at all times.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees