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.
Study Start-Up Manager, Malaysia (Remote)
Lead clinical trial site start-up and activation for ICON plc in Malaysia. Manage study start-up teams, regulatory submissions, timelines, budgets, and process improvements.
Opis
- Oversee daily site start-up and activation work.
- Coordinate the full study start-up cycle, from site selection and feasibility through regulatory submissions and activation.
- Guide and mentor a team of study start-up professionals.
- Work with sponsors, clinical operations, and regulatory teams to meet local and global requirements and timelines.
- Track start-up performance, schedules, and budgets.
- Assess start-up risks and put mitigation plans in place.
- Improve study start-up processes to increase efficiency.
Zahteve
- Hold a bachelor’s degree in a relevant science or healthcare field.
- Bring substantial experience in clinical trial start-up, with strong knowledge of global regulatory requirements and clinical operations.
- Have a track record of leading and mentoring teams in fast-paced, deadline-focused settings.
- Demonstrate strong organization and project management skills, including the ability to oversee multiple studies and competing priorities.
- Communicate effectively and manage relationships with sponsors and internal stakeholders.
- Have experience improving processes and applying best practices to study start-up work.
- Be willing to travel as needed, approximately 25%.
- Have legal authorization to work in Malaysia.
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 assurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Structured training and career pathways for learning and development.