Senior Project Manager

PRA International; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Join a leading global clinical research organization as a Senior Project Manager. You will oversee complex clinical studies, ensuring compliance and strategic alignment. This role demands strong project management skills, regulatory knowledge, and experience in leading cross-functional teams, offering the opportunity to make a significant impact in clinical research.

Benefits

Annual leave

Health insurance

Retirement plans

Employee Assistance Program

Life assurance

Flexible benefits

Qualifications

• 6+ years in pharmaceutical or clinical research.
• 4+ years in clinical study management.
• Fluent in business English.

Responsibilities

• Oversee execution of complex studies in clinical programs.
• Plan operational strategies for clinical trials.
• Manage site relationships and regulatory inspections.

Skills

Project management

Timeline and budget management

Risk management

Communication

Vendor oversight

Education

Bachelor’s Degree or equivalent

Life Sciences preferred

Job description

Overview

As a Senior Project Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Support or oversee the execution of complex studies in assigned clinical programs, ensuring compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs), on schedule and within budget.
• Oversee Strategic Partners, CROs, and vendors to meet Takeda’s obligations and business objectives.
• Plan and execute operational strategies for clinical trials; provide subject matter expertise on study documents.
• Lead development of Operational Strategy during Early Engagement with partners, focusing on assumptions and risk management.
• Provide oversight and guidance to ensure study issues are addressed promptly.
• Assist in study budget planning, management, and external spend; coordinate with finance and project teams.
• Review database timelines and plans; ensure linkage between strategy and tactical plans for database lock and CSR.
• Support data review for database lock and CSR, including appendices.
• Manage study documentation for TMF and regulatory filings.
• Oversee study financial reconciliation.
• Ensure studies are inspection-ready; assist in regulatory inspections.
• Manage site relationships, audits, and CAPAs.
• Prepare for agency inspections, including document readiness and tracking.

Qualifications

You are:

• Bachelor’s Degree or equivalent; Life Sciences preferred.
• Knowledge of global regulatory requirements (US CFR, EU CTD, ICH GCP) and local regulations.
• Experienced in project management, timeline and budget management, risk management.
• Highly organized, independent, with good communication skills.
• Proven experience leading cross-functional teams, vendor oversight, and managing recruitment/enrollment challenges.
• Fluent in business English.
• 6+ years in pharmaceutical or clinical research, with 4+ years in clinical study management or oversight, including early or late-phase studies, global/international programs.

What ICON offers: We value high performance and talent development. Benefits include annual leave, health insurance, retirement plans, Employee Assistance Program, life assurance, and flexible benefits. Visit https://careers.iconplc.com/benefits for more.

ICON is committed to inclusion and diversity. We provide an accessible environment and prohibit discrimination. For accommodations, contact us through the provided link. We encourage you to apply even if you don’t meet all requirements, as you may still be the right fit.