ICON plc ir globāla līgumizpētes organizācija, kas apkalpo veselības aprūpes un farmācijas nozares. Tās darbība ietver klīniskos, konsultāciju un komerciālos pakalpojumus, kas atbalsta zāļu izstrādi no agrīnas izpētes līdz darbībām pēc zāļu nonākšanas tirgū. Uzņēmums piedāvā decentralizētus klīniskos pētījumus, sirds drošuma novērtēšanu, agrīnās klīniskās laboratorijas pakalpojumus, medicīnisko attēlveidošanu, regulatīvo informāciju un reālās pasaules pierādījumu risinājumus. ICON plc ir arī terapeitiskā kompetence tādās jomās kā sirds un asinsvadu slimības, onkoloģija, iekšķīgās slimības, šūnu un gēnu terapijas, kā arī bioloģiski līdzīgas zāles. Apvienojot datu analīzi ar uz pacientu vērstām pieejām, uzņēmums palīdz attīstīt klīniskās programmas.
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.
Apraksts
- 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.
Prasības
- 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.
Priekšrocības
- 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.