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