ICON plc je globalna pogodbena raziskovalna organizacija, ki zagotavlja storitve za zdravstveno in farmacevtsko industrijo. Njeno delo vključuje klinične, svetovalne in komercialne storitve, ki podpirajo razvoj zdravil od zgodnjih raziskav do dejavnosti po prihodu na trg. Podjetje ponuja rešitve, kot so decentralizirane klinične raziskave, ocenjevanje srčne varnosti, laboratorijske storitve za zgodnje klinične raziskave, medicinsko slikanje, regulatorne informacije in dokazi iz resničnega sveta. ICON plc ima tudi terapevtsko strokovno znanje na področjih, kot so bolezni srca in ožilja, onkologija, interna medicina, celične in genske terapije ter podobna biološka zdravila, pri čemer združuje analizo podatkov s pristopi, osredotočenimi na paciente, da pomaga napredovati klinične programe.
Global Study Associate Director, CVRM
Lead global cardiovascular and cardiometabolic clinical trials at ICON, overseeing study execution, budgets, vendors, timelines, and quality.
Opis
- 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.
Zahteve
- 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.
Ugodnosti
- 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.