Clinical Study Manager

Study Manager

The Clinical Study Manager plays a pivotal role in delivering and executing global clinical studies under the guidance of a Study Delivery Lead. This role emphasizes tactical study delivery and involves reporting to a Director or a higher-level position. It requires excellent communication, project management skills, and meticulous attention to detail. The Clinical Study Manager interacts routinely with key internal and external stakeholders to convey project status, resolve issues, and address routine inquiries. This role may also involve responsibilities related to both operational strategy and study execution.

Responsibilities

• Provide leadership for a large-scale global clinical trial across the U.S., Europe, and Asia-Pacific regions.
• Manage critical study start-up activities, including central laboratory specifications, regulatory package review, site activation support, and cross-functional study execution.
• Oversee and manage CROs and third-party vendors.
• Handle EU Clinical Trials Regulation (EU CTR) responsibilities.
• Collaborate with global stakeholders across multiple time zones.
• Drive study milestones while ensuring quality, compliance, and operational efficiency.

Essential Skills

• 8+ years of clinical trial management experience.
• Strong experience managing global Phase I and/or Phase II studies.
• Oncology background required; lung oncology experience is highly preferred.
• Demonstrated experience overseeing vendors and leading complex, multi-country studies across the U.S., EU, and APAC regions.
• Familiarity with EU Clinical Trials Regulation (EU CTR).
• Ability to operate independently with minimal training.

Additional Skills & Qualifications

• Bachelor of Science degree required.
• Experience in clinical operations leading Phase II or III global studies.
• Prior experience working for a Japanese company is a plus.
• Experience as a Clinical Research Associate (CRA) is a plus.
• Ability to adapt quickly to a fast-paced environment.
• Strong collaboration skills.
• Excellent written and oral communication skills.

Work Environment

The position is 100% remote but candidates must be in the Eastern Time Zone or local to the NJ/PA/NY area. Flexibility for face-to-face meetings is desired.

Job Type & Location

This is a Contract to Hire position based out of Basking Ridge, NJ.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Aug 25, 2026.