Senior Project Manager

Pharmaceutical Research Associates, Inc; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading clinical research organization seeks a Senior Project Manager to support execution of complex clinical studies. The role involves overseeing compliance with quality standards, managing site relationships, and ensuring readiness for inspections. The ideal candidate has extensive experience in the pharmaceutical industry and will benefit from ICON's diverse culture and various employee perks.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Life assurance

Optional benefits like childcare vouchers

Gym memberships

Travel discounts

Health assessments

Qualifications

• 6+ years in pharmaceutical or CRO industry.
• 4+ years in clinical study management or oversight.
• Fluent in business English.

Responsibilities

• Oversee execution of complex studies, ensuring compliance.
• Plan operational strategies for clinical trials.
• Manage site relationships and oversee trial audits.

Skills

Project management

Regulatory knowledge

Risk management

Communication

Leadership

Education

Bachelor’s Degree or equivalent

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 and CROs to meet Takeda’s obligations and business objectives.
• Plan and execute operational strategies for clinical trials, providing expertise and input into study documents.
• Lead development of operational strategies during early engagement with partners, focusing on assumptions and risk management.
• Provide oversight and guidance to ensure rapid resolution of study issues.
• Assist in study budget planning, management, and external spend, working closely with relevant departments.
• Review database timelines and plans, ensuring 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 and support regulatory inspections.
• Manage site relationships and oversee trial audits, including CAPA follow-up.
• 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.
• Experience in project/program management, including timeline, budget, and risk management.
• Highly organized, independent, and communicative.
• Proven ability to lead cross-functional teams and manage recruitment/enrollment challenges.
• Fluent in business English.
• 6+ years in pharmaceutical or CRO industry, with 4+ years in clinical study management or oversight, including experience with early or late-phase studies, global/international programs.

What ICON can offer you: We prioritize building a diverse culture that rewards high performance and nurtures talent. Benefits include:

• Various annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Optional benefits like childcare vouchers, gym memberships, travel discounts, health assessments, etc.

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON is committed to inclusion and diversity. We provide an accessible environment and equal opportunity employment. For accommodations, please contact us through the provided form: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you are unsure about meeting all requirements — you might be exactly what we’re looking for!