Parexel — жаңа дәрі-дәрмектерді әзірлеудің барлық кезеңдерінде биофармацевтикалық компанияларға қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның қызметі I–IV фазалардағы клиникалық зерттеулерді, портфель мен зерттеулерді басқаруды, реттеуші стратегияны, нарыққа қолжетімділікті және дәрі-дәрмектің өмірлік циклін жоспарлауды қамтиды. 21 000-нан астам маманы бар Parexel клиникалық, реттеуші және терапиялық сараптаманы пациенттер туралы түсініктермен және инновациялық зерттеу үлгілерімен ұштастырады. Компания онкология, нейроғылым және сирек кездесетін ауруларды қоса алғанда, әртүрлі бағыттардағы зерттеулерге қолдау көрсетіп, клиникалық әзірлеу үдерісін тиімдірек әрі пациентке бағдарланған етуге назар аударады.
Clinical Trial Manager, Oncology FSP – UK Remote
Lead oncology clinical trials for Parexel from a home-based UK role. Manage vendors, sites, CRAs, regulatory compliance, study documentation, and trial delivery.
Сипаттама
- Join the sponsor’s Development Operations team.
- Manage assigned clinical trials or programs within the Clinical Trial Working Group.
- Plan and support trial start-up, execution, and delivery.
- Oversee external vendors and contract research organisations.
- Develop study documents, including monitoring, operations, source data verification, and laboratory manuals.
- Coordinate essential study materials, including CRFs, patient diaries, participation cards, and source documents.
- Support protocol development and completion of study reports.
- Oversee monitoring activities, including possible routine on-site monitoring, in line with GCPs, SOPs, and study protocols.
- Provide direction and management to CRAs.
- Track enrollment, qualify and manage sites through closeout, review site reports, and support data management coordination.
- Coordinate clinical trial supplies.
- Negotiate contracts with clinical trial service vendors.
- Review informed consent forms, CRFs, and other study materials.
- Plan and participate in investigator meetings.
- Support the data query process.
- Maintain investigational-site compliance with sponsor SOPs, FDA requirements, and ICH guidelines.
- Keep the trial master file current and properly maintained.
Талаптар
- A bachelor’s degree, nursing degree, or equivalent is required; a science background is preferred.
- At least five years of industry experience in pharmaceutical, biotechnology, or CRO clinical studies.
- Relevant clinical trial experience, including strong pharmaceutical-industry CRA performance across biotechnology, pharmaceutical, CRO, or medical-device settings.
- Demonstrated experience managing clinical trials.
- Experience managing or leading people in a matrixed organisation.
- Working knowledge of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes.
- Ability to work independently and collaboratively.
- Proficiency with Microsoft Office applications such as Word, Excel, PowerPoint, and Outlook.
- Strong written and verbal communication, organisation, and coordination skills.
- Willingness to work outside standard hours when business needs require it.
Артықшылықтар
- Home-based remote work arrangement within the UK.
- Ongoing opportunities for professional learning.
- Career development and skills expansion across clinical research.
- Flexibility and room to perform at your best.