Clinical Study Manager – Global Trial Delivery

1001 Syneos Health, LLC; Morrisville (NC); Hybrid; USD 90,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Medical, Dental and Vision benefits

401k with company match

Employee Stock Purchase Plan

Commissions/bonus eligibility

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Study Manager to oversee interdisciplinary clinical research studies and ensure GCP compliance across projects in the US. This role requires strong organizational skills and the ability to lead cross-functional teams to deliver on timelines and budgets.

As a liaison between the company and clients, you will drive study launches, conduct, and closeouts, manage TMF quality, and contribute to risk mitigation and contingency planning. Travel around 25% is expected.

Qualifications

• Bachelor’s degree in life sciences or healthcare field and related experience.
• Experience with CROs and therapeutic areas is preferred.
• Solid knowledge of GCP/ICH and regulatory requirements.

Responsibilities

• Lead interdisciplinary clinical research studies and ensure GCP compliance.
• Serve as primary liaison between company and customer to ensure study milestones.
• Guide project teams to meet quality, timelines and budget.
• Be accountable for project financial performance and deliverables.
• Coordinate study conduct partners and mitigate issues proactively.
• Maintain TMF and study data across systems and databases.
• Prepare management reports and present at meetings.
• Develop contingency planning and risk mitigation strategies.

Skills

GCP/ICH knowledge

Strong organizational skills

Excellent communication skills

Time management

Travel 25%

Education

Bachelor’s Degree in life sciences, Medicine, Pharmacy, Nursing or equivalent

Job description

Syneos Health is seeking a Study Manager to oversee interdisciplinary clinical research studies and ensure GCP compliance across projects in the US. This role requires strong organizational skills and the ability to lead cross-functional teams to deliver on timelines and budgets.

As a liaison between the company and clients, you will drive study launches, conduct, and closeouts, manage TMF quality, and contribute to risk mitigation and contingency planning. Travel around 25% is expected.