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Clinical Study Manager

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2016.12.02.
Jelentkezési határidő: 2016.12.14.
Hirdetés azonosító: 1094917


Clinical Study Manager
The CSM is accountable for planning, executing and reporting on a number of phase I-III, global phase IV clinical studies for Hungary, from planning and site feasibility through study close-out, in compliance with the company processes and regulatory requirements. This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs and CPOs

The main responsibilities of the Clinical Study Manager will be:
  • Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel
  • In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country
  • Ensure that activities and documentations from study start-up to close-out phasis are completed on time and related to the companies and local regulations in collaboration with the local Qualified Person.
  • Provide training as needed for monitors and any other activities that support site readiness to recruit.
  • Communicate with field monitors on a regular basis
  • Lead and chair local study team meetings, attend and participate in global clinical trial team meetings
  • Track trial budget
  • Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
  • Facilitate internal audits and HA inspections as required.
  • Timely submission and delivery of high quality clinical trial documentation
  • Acceptability of clinical documentation by IRB/EC and Health Authorities
  • No direct reports : leads a team in a matrix organization
  • Makes decisions relative to country participation and commitments. Resolve issues with minimal supervision and understand when to escalate
  • Key to ensure that the company led studies are executed according to internal and external standards and regulations, and that the company reputation as a credible, ethical and preferred partner is maintained/enhanced
  • Willingness from investigators to work with the company

The main requirements of the Clinical Study Manager are:
  • Degree in scientific of healthcare discipline. Master degree preferred
  • Advanced English written and spoken
  • Ideally 7+ years pharmaceutical industry experience with 5 years’ strong experience in clinical research
  • Experience in a monitor role or a role overseeing clinical trials
  • Strong Interpersonal skills
  • Strong Project Management and leadership skills
  • Ability to work in a matrix environment
  • Displays innovative ideas and solutions
  • Highly effective in influencing others
  • Thought leader in job role

Company offers:
  • Competitive salary package
  • Yearly bonus
  • Caffeteria
  • Company car for private usage as well

What you need to do now:
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Munkavégzés helye: Budapest

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