Clinical Study Manager

About the role

We are seeking an experienced Clinical Study Manager onsite in Durham, North Carolina to provide operational leadership and oversight for clinical studies from start-up through close-out. This role will coordinate study activities, manage vendor and CRO relationships, support study deliverables, and ensure clinical trials are conducted in compliance with applicable regulations, study protocols, and quality standards.

Responsibilities

• Clinical Study Management
  • Provide day-to-day operational oversight for assigned clinical studies from study start-up through close-out.
  • Coordinate study activities with internal teams, CROs, vendors, investigators, and study sites to support timely execution of project milestones.
  • Monitor study progress, timelines, deliverables, risks, and action items to ensure study objectives are achieved.
  • Identify operational challenges and implement mitigation strategies to address potential delays or risks.
  • Support study status reporting and communicate progress, issues, and recommendations to key stakeholders.
• Vendor & CRO Oversight
  • Support vendor selection activities, including review of proposals, scopes of work, budgets, and study planning documents.
  • Manage CRO and vendor relationships to ensure performance expectations, timelines, and quality standards are met.
  • Evaluate vendor performance metrics and proactively address performance concerns.
  • Coordinate training activities and ensure study personnel are appropriately trained and qualified.
  • Support oversight of vendor documentation, staffing changes, and milestone achievement.
• Study Documentation & Compliance
  • Support management and maintenance of the Trial Master File (TMF), including document review, reconciliation, filing, and quality control activities.
  • Review, draft, and maintain study-related documentation, including plans, manuals, reports, informed consent forms, and supporting study materials.
  • Ensure study documentation remains inspection-ready and compliant with applicable regulations, guidelines, and procedures.
  • Support audit readiness activities and assist with the resolution of monitoring findings, audit observations, and study conduct issues.
• Cross-Functional Collaboration
  • Partner with Clinical Operations, Data Management, Biostatistics, Safety, Regulatory Affairs, Clinical Supply, Contracts, and other functional teams to support study execution.
  • Participate in cross-functional study meetings and facilitate communication among stakeholders.
  • Provide operational input to study plans, data review activities, and study management processes.
  • Support study-specific training initiatives for investigators, site personnel, vendors, and study teams.
• Financial & Operational Support
  • Assist with study, vendor, and site budget management activities.
  • Review invoices to verify work performed aligns with approved budgets and agreements.
  • Support financial tracking, forecasting, and contract-related activities.
  • Contribute to study planning, resource forecasting, and operational process improvements.

Requirements

• Minimum 8 years of clinical research experience.
• At least 2 years of clinical study management, clinical operations, or related study leadership experience.
• Experience managing CROs, vendors, clinical sites, and cross-functional study teams.
• Experience overseeing study start-up, maintenance, and close-out activities.
• Experience supporting TMF management, clinical documentation, and inspection readiness activities.
• Sponsor-side clinical study management experience preferred.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related field preferred. Equivalent combination of education and relevant clinical research experience may be considered.

Skills

• Strong knowledge of clinical trial operations and clinical study management.
• Thorough understanding of ICH-GCP guidelines, regulatory requirements, and clinical research best practices.
• Experience managing CROs, vendors, study timelines, and cross-functional deliverables.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Excellent problem-solving and decision-making capabilities.
• Strong verbal and written communication skills.
• Ability to build effective relationships with internal and external stakeholders.
• Detail-oriented approach with a commitment to quality and compliance.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Proficiency with clinical systems and tools, including CTMS, eTMF, EDC, and Microsoft Office applications.

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits