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 Responsibilities
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, 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 operational risks.
Qualifications & Experience
Education
- Bachelor’s degree (or equivalent) in Life Sciences (e.g., Biology, Chemistry, Nursing, Pharmacy).
- Base: