Global Study Associate Director
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In this role you drive the delivery of clinical studies within Study Management, partnering with cross-functional teams to meet timelines, budget, and quality standards. You act as the primary liaison between study teams and the Clinical Program Team, guiding investigators and external partners through study handover to close-out. You ensure governance, risk management, and compliance with ICH-GCP, SOPs, and policies while supporting professional development within the team. You work to optimize study plans, budgets, and TMF quality, delivering initiatives that improve study performance. This is an impactful leadership position at IQVIA with a focus on delivering high-quality trials at scale
Responsabilidades- Lead cross-functional study teams or oversee outsourced delivery to meet milestones, timelines, budgets, and quality
- Facilitate communication across functions and with external partners; lead investigator and study-related meetings
- Contribute to essential study documents (CSP through CSR) per SOPs
- Oversee external service providers (CROs, labs, IXRS, ePRO) for contracted performance and escalate issues
- Develop and maintain study plans including quality and risk management planning with clear risk response strategies
- Ensure data in study systems (e.g., ACCORD/ABACUS, PharmaCM) is current and accurate
- Monitor study performance against plans and KPIs, report risks with mitigations to CPT and DSM
- Identify and report quality issues, implement CAPAs, and communicate findings to stakeholders
- Oversee TMF completion and QC activities to ensure completeness
- Ensure compliance with governance controls and financial attestations
- Manage study budget re-forecasting and provide budget progress reports with risks
- Ensure inspection-readiness and act as study management point-of-contact during audits
- Provide performance feedback and mentor team members; contribute to process improvements
- May serve as Subject Matter Expert for a study-management process or system
- May participate in vendor selection activities
- University degree (or equivalent)
- 5 years of relevant clinical experience in pharma
- 2 years’ project management experience or equivalent
- Strong knowledge of ICH-GCP and clinical research regulations
- Proven project management skills and relevant tools
- Demonstrated leadership and team management abilities
- Excellent communication and interpersonal skills
- Strong strategic thinking, problem-solving, and organizational skills
- Ability to manage competing priorities
- Strong relationship-building with internal and external stakeholders
- Conflict management skills
- Experience with study management processes and drug development
- leadership
- communication
- stakeholder management
- ICH-GCP knowledge
- risk management planning
- TMF management
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