Clinical Trial Manager

Randstad USA; North Carolina; Hybrid; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking an experienced Clinical Trial Study Manager for a 12-month hybrid contract role based in Durham, NC. The role involves overseeing end-to-end study operations across oncology, ophthalmology, and biologics trials, ensuring adherence to GCP/ICH guidelines. Candidates should have strong project management experience and the ability to manage vendor performance effectively.

Benefits

Comprehensive benefits package

401K plan

Short-term disability

Medical, prescription, dental, vision insurance

AD&D and life insurance

Qualifications

• Extensive hands-on clinical trial management experience on the sponsor side.
• Strong vendor and CRO management capabilities.
• Therapeutic area expertise in oncology, ophthalmology, or biologics.

Responsibilities

• Lead the full lifecycle of clinical trials ensuring compliance.
• Manage third-party vendors and CROs for study execution.
• Draft, review, and maintain essential study documents.

Skills

CTMS

Vendor Management

CRO Management

Risk Mitigation

Budgeting

Education

Bachelor's Degree

Tools

Electronic Data Capture Platforms

Clinical Trial Management Systems

Job description

job summary:
We are seeking an experienced Clinical Trial Study Manager for a 12-month hybrid contract role based in Durham, NC (3 days onsite, 2 days remote). This role will lead end-to-end study operations across oncology, ophthalmology, and biologics trials, ensuring adherence to GCP/ICH and regulatory requirements. The ideal candidate will bring recent sponsor-side project management experience, along with prior CRO collaboration, and a strong drive to manage vendor performance. Key responsibilities include vendor oversight, cross-functional collaboration, regulatory and clinical documentation development, risk management, and budget/invoice review. This position demands excellent leadership, communication, and organizational skills to ensure high-quality, timely, and cost-effective study execution.


location: Durham, North Carolina
job type: Contract
salary: $57 - 71 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• End-to-End Study Management: Lead the full lifecycle of clinical trials from planning through close-out, ensuring compliance with GCP/ICH guidelines, SOPs, and regulatory requirements; oversee timelines, risks, budgets, and milestone achievement across internal teams and external partners.
• Vendor & Cross-Functional Oversight: Manage third-party vendors and CROs, including performance evaluation, audit response, and corrective action planning; collaborate closely with Biometry, Supplies, and Contracts to ensure alignment and timely execution of study deliverables.
• Clinical Documentation, Data & Quality Management: Draft, review, and maintain essential study documents (e.g., protocols, CSRs, ICFs); ensure proper documentation in CTMS and Trial Master File; uphold data integrity, oversee training, and resolve escalated study conduct or compliance issues.

qualifications:
Required:

• Extensive hands-on clinical trial management experience on the sponsor side, with full study oversight from initiation to close-out and prior CRO experience to navigate both sponsor and vendor dynamics.
• Strong vendor and CRO management capabilities, including timeline development, milestone tracking, risk mitigation, and regulatory documentation (protocols, CSRs, ICFs) aligned with GCP/ICH guidelines.
• Therapeutic area expertise in oncology, ophthalmology, or biologics

?Preferred:

• Prior experience working at or with a CRO to understand both sponsor and vendor perspectives.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
• Experience in financial oversight, including budgeting, invoice review, and contract management.

#LI-AB1


skills: CTMS (Clinical Trial Management Systems)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Required:

• Extensive hands-on clinical trial management experience on the sponsor side, with full study oversight from initiation to close-out and prior CRO experience to navigate both sponsor and vendor dynamics.
• Strong vendor and CRO management capabilities, including timeline development, milestone tracking, risk mitigation, and regulatory documentation (protocols, CSRs, ICFs) aligned with GCP/ICH guidelines.
• Therapeutic area expertise in oncology, ophthalmology, or biologics

?Preferred:

• Prior experience working at or with a CRO to understand both sponsor and vendor perspectives.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
• Experience in financial oversight, including budgeting, invoice review, and contract management.

#LI-AB1