Senior Project Manager

ICON; Village of Farmingdale (NY); On-site; USD 100,000 - 140,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Project Manager to oversee complex studies and ensure compliance with quality standards. This role involves managing strategic partners and optimizing operational strategies for clinical trials while ensuring thorough documentation and readiness for inspections.

Benefits

Competitive salary and benefits

Health insurance

Retirement plans

Employee Assistance Program

Flexible benefits

Qualifications

• Bachelor’s Degree in Life Sciences preferred.
• Knowledge of US CFR, EU CTD, ICH GCP.
• 6+ years in pharmaceutical or clinical research, including 4+ in study management.

Responsibilities

• Oversee execution of clinical studies ensuring compliance and budget adherence.
• Plan and execute operational strategies for clinical trials.
• Manage relationships with partners, CROs, and vendors.

Skills

Project Management

Risk Management

Communication Skills

Interpersonal Skills

Regulatory Knowledge

Education

Bachelor’s Degree or equivalent

Job description

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

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.
• Manage Strategic Partners, CROs, and vendors to meet Takeda’s obligations and business objectives.
• Plan and execute operational strategies for clinical trials, providing expertise on protocol development and related documents.
• Lead development of Operational Strategy during early engagement with partners, focusing on assumptions and risk management.
• Oversee study issues resolution, budget planning, and management, ensuring alignment with project goals and financial oversight.
• Collaborate with data management to ensure database timelines and plans are met, supporting data review and regulatory submissions.
• Ensure study documentation is complete and audit-ready, supporting inspections and regulatory filings.
• Manage site relationships, trial audits, and follow-up on audit findings and CAPAs.
• Prepare for agency inspections and oversee document readiness.

You are:

• Bachelor’s Degree or equivalent; Life Sciences preferred.
• Knowledge of global regulatory requirements (US CFR, EU CTD, ICH GCP) and local regulations.
• Proven experience in project/program management, risk management, and leading cross-functional teams.
• Highly organized, independent, with strong communication and interpersonal skills.
• At least 6+ years in pharmaceutical or clinical research, including 4+ years in clinical study management or oversight, with experience in early or late-phase, global studies.

What ICON can offer you:

• Competitive salary and benefits focused on well-being and work-life balance.
• Examples include various leave entitlements, health insurance, retirement plans, Employee Assistance Program, life assurance, and flexible benefits.

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

ICON values inclusion & belonging, providing a discrimination-free workplace. For accommodations during the application process, please contact us through the provided link.

We encourage you to apply even if you do not meet all requirements, as you may still be a great fit.