ICON plc este o organizație globală de cercetare în regim contractual, care deservește industriile din domeniul sănătății și farmaceutic. Activitatea sa cuprinde servicii clinice, de consultanță și comerciale care sprijină dezvoltarea medicamentelor, de la cercetarea timpurie până la activitățile post-comercializare. Compania oferă soluții precum studii clinice descentralizate, evaluarea siguranței cardiace, laboratoare clinice pentru etapele timpurii, imagistică medicală, informații de reglementare și dovezi din lumea reală. ICON plc dispune, de asemenea, de expertiză terapeutică în domenii precum bolile cardiovasculare, oncologia, medicina internă, terapiile celulare și genice și medicamentele biosimilare, combinând analiza datelor cu o abordare axată pe pacienți pentru a contribui la avansarea programelor clinice.
Global Study Associate Director, CVRM
Lead global cardiovascular and cardiometabolic clinical trials at ICON, overseeing study execution, budgets, vendors, timelines, and quality.
Descriere
- Lead global study teams through the full lifecycle of cardiovascular clinical trials.
- Manage study timelines, budgets, quality goals, and key milestones.
- Act as the primary operational contact for study teams, CROs, and external partners.
- Oversee outsourced work through effective vendor management and study oversight.
- Direct study planning, risk management, issue resolution, and escalations.
- Maintain Trial Master File quality and inspection readiness.
- Manage study budgets, forecasts, and operational reporting.
- Support audits, regulatory inspections, and process improvement.
- Lead the delivery of global cardiovascular and cardiometabolic clinical trials.
Cerințe
- Hold a degree in life sciences, clinical research, or a related field.
- Bring substantial global experience in pharmaceutical or biotechnology clinical development.
- Demonstrate a track record leading global clinical studies and cross-functional teams.
- Know ICH-GCP, clinical trial regulations, and study management principles well.
- Have experience managing study budgets, vendors, timelines, and operational risks.
- Show strong leadership, stakeholder management, communication, and organizational skills.
- Experience with cardiovascular or cardiometabolic clinical trials is highly desirable.
- A master's degree, PhD, or equivalent is preferred.
- Project management certification is preferred.
- Experience delivering large-scale global studies across multiple development phases is preferred.
- Prior involvement in cardiovascular outcomes research or late-phase cardiovascular trials is advantageous.
- Have legal authorization to work in France.
Beneficii
- Competitive base pay with performance-related incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life insurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Learning and development through structured training and career pathways.