Trial Delivery Manager, Sponsor Dedicated

Durham, North Carolina, United States of America

Full time

R1570300

Clinical Trial Management & Central Trial Oversight (FSP Model)

Home Based Remote Role - East Coast

IQVIA is seeking an accomplished Senior Project Lead / Associate Director, Clinical Trial Management to provide centralized, global clinical trial oversight within our Functional Service Provider (FSP) model. This role partners closely with a Global Trial Leadership and cross-functional stakeholders to ensure the successful planning, execution, and delivery of complex clinical trials across regions and vendors.

You will lead Study Management Teams (SMTs), oversee country and site-facing activities, and ensure trials are conducted with the highest standards of quality, compliance, and inspection readiness—from start-up through close-out. This role is ideal for a senior clinical operations professional who thrives in a matrixed, global environment and is ready to influence strategy, mentor teams, and drive operational excellence.

Global & Regional Trial Leadership

• Lead and coordinate global and regional clinical trial management activities for internally managed and outsourced studies.

• Serve as a core member of the Trial Team, partnering with Global Leadership to deliver operational strategy and execution.

• Act as primary point of contact for country, regional, and functional stakeholders within Clinical Development Operations.

• Function as backup or first point of contact in the absence of the Global Leadership.

Central Trial Oversight & Execution

• Drive trial delivery across the full lifecycle: feasibility, site selection, start-up, execution, and close-out.

• Ensure milestones, timelines, and deliverables are met and transparently communicated.

• Maintain real-time trial oversight through dashboards, reports, and issue tracking.

• Act as the central subject matter expert for assigned protocols.

Vendor & Partner Management

• Provide oversight of CROs and global vendors supporting site-facing activities, including:

• IWRS/IVRS

• Central Laboratory

• ePRO/eCOA

• Imaging

• Translation and printing

• Ancillary supplies and investigator meetings

• Review and approve vendor deliverables, invoices, and spend.

• Ensure vendor performance aligns with trial plans, budgets, and quality expectations.

Quality, Compliance & Inspection Readiness

• Ensure continuous inspection readiness in accordance with ICH-GCP, applicable regulations, and sponsor SOPs.

• Lead or contribute to CAPA development and resolution.

• Support Health Authority inspections, internal audits, and quality reviews.

• Partner with Quality & Compliance stakeholders to ensure effective oversight.

Enrollment, Feasibility & Risk Management

• Lead feasibility activities and provide data-driven recommendations.

• Establish and track regional enrollment commitments, ensuring alignment with projections.

• Ensure robust recruitment and contingency plans are in place.

• Proactively identify risks, elevate issues, and drive resolution.

Documentation, Systems & Trial Deliverables

• Oversee trial documentation, filing, archiving, and retention.

• Create, review, and maintain trial-specific documents, including:

• Monitoring Guidelines

• Informed Consent Forms

• IMP and blinding documentation

• Feasibility and site selection materials

• Support HA/EC/IRB submissions with required central documents.

• Coordinate data cleaning activities to support timely database lock.

Leadership, Mentorship & Continuous Improvement

• Lead teams across projects or programs.

• Provide coaching and mentoring to less experienced team members.

• Lead or participate in special initiatives, task forces, and process improvement efforts.

• Contribute innovative ideas to enhance operational efficiency and quality across the FSP partnership.

(Base Level)

• Independe…