Lead Clinical Study Manager — Drive Trial Delivery

Belcan Corporation; Durham (NC); On-site; USD 77,145 - 97,809; Full time

Job summary

Belcan Corporation in Durham, NC is seeking a Contract Clinical Study Manager to provide operational leadership and oversight for assigned studies, ensuring adherence to ICH/GCP, regulatory requirements, SOPs, and study plans across CROs, vendors, investigators, and sites.

You will coordinate with cross-functional teams, develop timelines, monitor milestones, support budget development, review study documents and audits, and maintain TMF and data integrity to support inspection readiness.

Qualifications

• Bachelor’s degree in life sciences or related field preferred; equivalent directly related experience may be considered.
• At least eight years of clinical research experience, including two years in study management or related roles.
• Experience working with CROs, vendors, clinical sites, and cross-functional teams is required.
• Sponsor-side study management, vendor oversight, TMF management, and audit/inspection readiness preferred.

Responsibilities

• Provide day-to-day study management support for assigned activities from start-up through close-out.
• Coordinate with CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Monitor adherence to essential document collection, site activation, and study-specific tracking tools.
• Lead meetings with CROs, vendors, and cross-functional teams to review progress, risks, issues, and action items.
• Develop timelines, deliverables, and mitigation plans to address delays or operational risks.
• Assist in vendor selection, including scopes of work, budgets, and planning documents.
• Evaluate CRO and vendor performance and escalate issues as needed.
• Develop corrective and preventive action plans as appropriate.
• Coordinate study training for CRO staff, investigators, and study coordinators.
• Oversee vendor staff qualifications, turnover documentation, and performance against milestones.
• Manage Trial Master File accuracy, filing, reconciliation, and quality control activities.
• Draft/review study documents including informed consent forms and site manuals.
• Support responses to site audits and monitoring findings.
• Ensure compliance with regulatory requirements, SOPs, and study protocols.
• Oversee CTMS tracking and study status reporting for set-up, conduct, and close-out.
• Review data listings, vendor reports, and monitoring trends for data integrity and GCP compliance.
• Provide input into case report forms, data management, and data transfer plans.

Skills

Study management

Regulatory compliance

Vendor management

Cross-functional leadership

Communication

Organization

CTMS familiarity

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS

eTMF

EDC

Microsoft Office

Job description

Belcan Corporation in Durham, NC is seeking a Contract Clinical Study Manager to provide operational leadership and oversight for assigned studies, ensuring adherence to ICH/GCP, regulatory requirements, SOPs, and study plans across CROs, vendors, investigators, and sites.

You will coordinate with cross-functional teams, develop timelines, monitor milestones, support budget development, review study documents and audits, and maintain TMF and data integrity to support inspection readiness.