Cristina De Gracia

Clinical Operations leader with 15+ years of experience in international clinical research, progressing from Clinical Research Associate to Associate Director. Extensive experience leading multidisciplinary teams across EMEA and LATAM, managing global clinical trial operations, strategic client partnerships, resources, budgets, operational performance, KPIs and risk. Strong scientific background with expertise in oncology, cross-functional leadership, process improvement and global clinical trial delivery (phase I – IV).

Complementing extensive Clinical Operations leadership experience with advanced training in Project Management, Artificial Intelligence and Innovation.

Associate Director, Clinical Operations - IQVIA

(2021-01 - 2026-07)

• Led multidisciplinary Clinical Operations teams of up to 25 professionals across EMEA and LATAM, including CTAs, CRAs, Lead CRAs, Clinical Project Managers and Project Managers.
• Led resource and capacity management, workforce forecasting and FTE allocation across multiple strategic partnerships, balancing project demand, staff assignments, timelines, budgets and client deliverables.
• Served as primary operational point of contact for strategic client partnerships, managing performance, escalations, KPIs, SLAs and stakeholder expectations.
• Led regional operational governance and partnership performance meetings with senior client stakeholders.
• Led operational risk assessments, issue escalations, quality oversight and CAPA management, driving process improvement and risk mitigation across global clinical programs.
• Partnered with Regulatory Affairs, Quality, Medical Affairs, Finance and Site Strategy to support successful program execution.
• Led recruitment, onboarding, performance management, coaching, development and succession planning across international teams.
• Supported budget planning, resource forecasting and operational financial oversight in collaboration with Finance and senior leadership.
• Performed oversight quality-control activities, including report review and inspection readiness; contributed to global manuals, training initiatives and leadership forums.

Operations Line Manager - ClinTec International (an IQVIA Company since Dec 2018; contract with Merck Sharp & Dohme)

(2017-02 - 2020-12)

• Directed a team of clinical staff supporting clinical trials, ensuring appropriate resourcing, training and performance in accordance with ICH-GCP, company policies, procedures and quality standards.
• Supported medical affairs activities, quality management, office and finance responsibilities, and global program initiatives.
• Coordinated people development, workload allocation, operational delivery and stakeholder communication across assigned studies.

Senior Quality CRA / Senior Clinical Research Associate, Oncology - Clintec working under contract with Merck Sharp & Dohme

(2014-11 - 2017-01)

• Oversaw oncology clinical trial conduct (phase I – III), patient safety, risk-benefit considerations, protocol compliance, MSD SOPs and regulatory requirements through on-site and remote monitoring.
• Performed site selection, initiation, routine monitoring and close-out activities; partnered with investigators and key opinion leaders.
• Collaborated cross-functionally with study teams and global clinical vendors, including central laboratories, imaging, eCOA/ePRO, patient-reported outcomes, ECG and IVRS/IWRS providers, supporting operational delivery, issue resolution and escalation.
• Supported audit and inspection readiness and contributed clinical quality expertise across study teams.

Clinical Research Associate / Senior Clinical Research Associate - ICON Clinical Research Spain, S.L.

(2010-06 - 2014-11)

• Monitored Phase II and III clinical trials, primarily in oncology, including lung, pancreatic, glioblastoma and breast cancer studies.
• Applied risk-based monitoring approaches and supported site initiation, monitoring, documentation quality and issue resolution.
• Mentored and supported new clinical staff and contributed to consistent study delivery.

Clinical Research and Scientific Roles - BioClever S.A. & Quintiles

(2010-01 - 2011-06)

• Supported clinical research activities across therapeutic areas including cardiovascular health and nutrition.
• Contributed to regulatory and ethics submissions, contracts, budgets, study documentation and stakeholder coordination.

Pharmacy Manager (UK & Spain)

(2005-01 - 2009-01)

Master - Project Management - OBS Business School & University of Barcelona

Master - Artificial Intelligence & Innovation - Founderz / Microsoft

Master's Degree - Clinical Research - University of Barcelona, Spain (2010)

Master's Degree - Nutrition and Metabolism - University of Barcelona (2009)

MS - Biochemistry - University of Barcelona (2008)

MS - Pharmacy - University of Barcelona (2007)

GCSE Qualifications - University of Cambridge, UK (1999)