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Acerca de nuestro cliente International biotechnology group committed to developing innovative therapies for the treatment and prevention of allergies Descripción Carrying out tasks as a (senior) Clinical Study Manager to support Phase I-III clinical...

Acerca de nuestro cliente

International biotechnology group committed to developing innovative therapies for the treatment and prevention of allergies

Descripción

  • Carrying out tasks as a (senior) Clinical Study Manager to support Phase I-III clinical trials
  • Project planning, organisation, implementation, monitoring and evaluation of clinical trials of phases I - III according to ICH-GCP, SOPs, applicable guidelines and regulations
  • Establishing and taking responsibility for study timelines, budgets for assigned vendors, invoices and external resource requirements
  • Selecting, evaluating and overseeing vendors, consultants and CRO's
  • Selecting, monitoring and overseeing trial sites e.g. sponsor oversight visits to the trial site
  • Supporting review of trial protocols and other documents e.g. investigator information, CRFs and Clinical Study Reports
  • Organizing, attending and presenting at investigator meetings
  • Filing and archiving of study documentation (e.g. electronic Trial Master File) to be "audit ready" at all times
  • Monitoring of current and upcoming activities for quality assurance
  • Helping to prepare and participating in audits and inspections and to prepare action plans to follow up on audit and inspection findings
  • Reviewing clinical data/ information and providing oversight of study status and progress
  • Contributing to the development of Standard Operating Procedures

Perfil Buscado (H/M/D)

  • Life Science Degree
  • At least 3 years experience as Clinical Study Manager or Coordinator
  • High level of english (minimum C1 or Advenced)
  • Knowledge and understanding of GCP and applicable regulatory environment
  • Strong organizational, interpersonal, written/ verbal/ influencing skills, with a strong attention to detail
  • Experience in leadership of clinical trial management, including management of CROs, multiple vendors and consultants
  • Experience with EDC systems, electronic clinical filing systems
  • Ability to learn company use of new technologies and software including SharePoint
  • Proficient user of Microsoft Office
  • Project management evidence based skills: cross functional team management
  • Excellent communication/interpersonal/customer service skills
  • Self-motivated with good problem solving skills
  • Prioritisation, organisation and planning skills
  • Innovative, enthusiastic, optimistic and motivating attitude
  • Adaptable, flexible, effective personal and time management in a rapidly changingenvironment
  • Openness with respect to computer systems and new technologies
  • Ability to travel regionally and internationally as needed

Qué ofrecemos

  • Barcelona or UK based.
  • 4 days Home Office 1 day Office
  • International team
  • Fix contract
  • Social benefits
  • Good environment and great team

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