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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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