Description
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.
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. + 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.
- 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. + 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.
Qualifications & Experience
- Education: Bachelor’s degree (or equivalent) in Life Sciences (e.g., Biology, Chemistry, Nursing, Pharmacy).
- Experience: 6+ years of clinical trial management experience in pharma and/or CRO environments.
- Technical & Professional Skills:
+ Deep knowledge of ICH-GCP, regulatory requirements, and clinical operations best practices. + Strong project management, planning, and risk mitigation skills. + Demonstrated ability to manage country and vendor budgets. + Experience with CTMS, TMF systems, and Microsoft applications. + Strong analytical, decision-making, and communication skills. + Fluent in English; local language proficiency as required.
Salary: The potential base pay range for this role, when annualized, is $93,100.00 - $295,500.00.