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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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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.

GBRegatul UnitRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

  • 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.

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