Jobs · Management · North Carolina

Trial Delivery Manager, Sponsor Dedicated

Hader Solutions · Durham, NC · 1 wk ago
On-siteManagementFull-time
Role Overview: The Senior Project Lead / Associate Director, Clinical Trial Management oversees global clinical trials within an FSP model, collaborating with cross-functional teams to ensure successful study planning, execution, and delivery. Key Responsibilities Lead and coordinate trial management activities across regions and vendors, acting as a primary contact for stakeholders.Drive trial lifecycle activities from feasibility to close-out, ensuring milestones and quality standards are met.Oversee vendor management, including CROs and support services, ensuring performance aligns with trial goals and budgets.Maintain inspection readiness, support audits, and ensure compliance with GCP and regulatory standards.Manage enrollment, risk mitigation, and trial documentation, supporting regulatory submissions and data activities.Provide leadership, mentorship, and contribute to process improvements for operational efficiency. Qualifications & Skills Bachelor’s degree in Life Sciences or related field; 6+ years (base) or 8+ years (advanced) of clinical trial management experience, including global studies.Strong knowledge of ICH-GCP, regulatory requirements, project management, and vendor oversight.Proficiency in CTMS, TMF systems, and Microsoft Office; monitoring experience preferred.Excellent communication, decision-making, and analytical skills; fluent in English and willing to travel. Level Differentiation: The base level manages complex trials independently, while the advanced level leads high-impact programs, mentors teams, and influences strategy.

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