Hybrid Clinical Study Manager

Creative Solutions Services, LLC; Durham (NC); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Contract Clinical Study Manager to provide operational leadership for assigned clinical studies. The role emphasizes adherence to ICH/GCP, collaboration with CROs, vendors, investigators, and study sites to deliver quality results on schedule.

This hybrid, M-F position requires coordinating start-up through close-out, overseeing TMF, and maintaining study documentation and budgets.

Qualifications

• Bachelor’s degree in life sciences or related field.
• At least 8 years of clinical research experience, including 2+ years in study management.
• Experience managing CROs, vendors, and clinical sites.
• Familiar with ICH/GCP guidelines and regulatory requirements.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide day-to-day study management from start-up through close-out.
• Coordinate with CROs, vendors, investigators, and sites to meet milestones.
• Monitor document collection, site activation, and study tracking tools.
• Lead meetings to review progress, risks, and action items.
• Develop study timelines, deliverables, and mitigation plans.
• Assist in vendor selection, budgeting, and planning documents.
• Review site audits and inspection responses.

Skills

Clinical trial operations

ICH/GCP compliance

Vendor management

Cross-functional coordination

CTMS experience

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in life sciences

8+ years clinical research experience

Tools

CTMS

EDC

TMF systems

Microsoft Office

Job description

Creative Solutions Services, LLC is seeking a Contract Clinical Study Manager to provide operational leadership for assigned clinical studies. The role emphasizes adherence to ICH/GCP, collaboration with CROs, vendors, investigators, and study sites to deliver quality results on schedule.

This hybrid, M-F position requires coordinating start-up through close-out, overseeing TMF, and maintaining study documentation and budgets.