Trial Delivery Manager, Sponsor Dedicated

## Trial Delivery Manager, Sponsor Dedicated Apply:
Durham, North Carolina, United States of America:
Full time:
Posted Today:
R1570300

Clinical Trial Management & Central Trial Oversight (FSP Model)
Home Based Remote Role - East Coast   
** Role Overview
** 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.  
** Key Responsibilitie
** sGlobal & 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, escalate 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.
** Level Differentiation** (Base Level)
* Independently manages complex trials with limited oversight.
* Demonstrates strong operational leadership and stakeholder management.
* Owns central trial oversight activities and delivers consistent, high-quality results. (Advanced Level)
* Leads program-level or high-impact trials with increased complexity.
* Manages and mentors multiple team members across insourced and outsourced studies.
* Serves as a Therapeutic Area Expert or Functional Champion, influencing strategy and best practices.
* Proactively identifies and resolves budget, resourcing, and…