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CLINICAL STUDY MANAGER

 

Company:

HARTLEY PEOPLE RECRUITMENT
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Job Reference Number

14563231

Client ID:

RI/HP4953X
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Posted On:

Jan 30 2012

Location:

WEXFORD
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Job Type:

Permanent

Salary:

NEGOTIABLE
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Our client, a leading multi-national healthcare company, currently have a vacancy for a Clinical Study Manager for their production facility which is based in the South East .

Remuneration: DOE

Contact: Hartley People Recruitment (Audrey O'Callaghan)

The main purpose of this role is to manage the Design Validation and Usability Studies to support product development of Class I and II medical device systems, methods and reagents.

The Person:

  • A minimum of a BSc in a scientific subject with a strong chemistry component
  • Project management experience essential
  • Have a proven track record of proactively managing 3rd party collaborators and external clinical study
  • Have knowledge of writing and reviewing IQ, OQ, PQ and Design Validation documentation and experience in drafting and reviewing SOPs
  • Have working knowledge of the Medical Device Design Control process, with demonstrable effective experience in a regulated environment preferably with a good understanding of Compliance requirements
  • Statistical analysis of analytical data and data storage, Knowledge of biostatistics would be desirable
  • Excellent organization and communication skills
  • Experience of working within a Quality Management System


Responsibilities:·

  • Manage clinical applications validation work using company products, in support of clinical projects
  • Work with project management in planning all aspects of design validation/clinical studies and ensure that the external clinical study requirements are completed within the time-scales agreed with project management and make recommendations to the team to improve timelines for project completion
  • Identify suitable collaborator sites for conducting design validation/clinical studies
  • Manage the acquisition of patient samples including IRB and Ethical approvals with external collaborators Obtain test compounds, study instrumentation and supplies required for design validation/clinical studies
  • Work with finance in developing and managing the budget for design validation/clinical studies
  • Work with legal in developing collaborator contracts, and contributing to contract development
  • Plan audits with the quality function and ensure external study sites and collaborators meet the company quality requirements for Medical Device product development activities
  • Design and implement clinical validation master plans, develop and implement design validation/clinical study protocols
  • Review and approve data from study sites and produce validation reports for regulatory submissions. Suggest corrective plans when appropriate
  • Oversee risk management activities at collaborator sites



For more information on this role, please send full CV via the link provided below or contact Audrey in confidence on 051-878813.