Senior Global Clinical Trial Lead — Rare Disease

ACTalent; United States; Hybrid; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

PTO & Vacation

Job summary

Actalent is hiring a Sr Clinical Trial Manager in the United States to lead planning, start-up, execution and close-out of global trials, with emphasis on rare and ultra-rare disease programs. You will coordinate CROs, vendors, and study sites to ensure compliance with ICH-GCP and regulatory standards, while driving on-time, on-budget delivery.

The role requires a track record of 10+ years in clinical operations, hands-on management of global Phase III/IV trials, and strong cross-functional

Qualifications

• 10+ years of clinical operations experience.
• Experience leading global Phase III/IV trials.
• Experience in rare or ultra-rare disease programs.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Ability to manage CROs and vendors.

Responsibilities

• Lead planning, initiation, execution, and close-out of global trials.
• Coordinate CROs, vendors, and sites to ensure compliance.
• Track timelines, enrollment targets, budgets, milestones.
• Develop and maintain core study documents; manage risk.
• Drive cross-functional communication and process improvements.

Skills

Ten years clinical ops

Phase III/IV trials

Rare/ultra-rare disease

GCP/ICH regulatory

CRO/vendor management

Cross-functional collaboration

Risk management

Operational planning

Communication skills

Independent worker

Education

Bachelor's in life sciences

Advanced degree preferred

Tools

CTMS

EDC

Job description

Actalent is hiring a Sr Clinical Trial Manager in the United States to lead planning, start-up, execution and close-out of global trials, with emphasis on rare and ultra-rare disease programs. You will coordinate CROs, vendors, and study sites to ensure compliance with ICH-GCP and regulatory standards, while driving on-time, on-budget delivery.

The role requires a track record of 10+ years in clinical operations, hands-on management of global Phase III/IV trials, and strong cross-functional