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STUDY DIRECTOR

 

Company:

CPL
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Job Reference Number

14347872

Client ID:

RI/JO098792
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Posted On:

Jul 29 2010

Location:

MAYO
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Job Type:

Permanent

Salary:

AS PER SCALE
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Based in the north west of Ireland, my clients are currently looking for a Study Director/Project Leader for their BioPharmaceutical Services Division.

The main duties of this role are as follows:

Draw up study plans and implement studies in strict accordance with plan ensuring full regulatory compliance. Day to day liaison with clients regarding current and new projects. Research and develop new methodologies to meet client requirements and/or company strategic objectives. Ensure all new methods are validated in accordance with ICH guidelines. Ensure all new equipment is qualified and validated in accordance with cGMP and corporate validation requirement standards and guidelines. Generate new and update current standard operating procedures Generate protocols, reports and risk assessments. The successful candidate must have:

A PhD in a relevant science discipline (preferably Analytical) A minimum of 2-3 years experience working in a cGMP regulated environment (EMEA/FDA) within the Pharmaceutical/CRO industry. Experience in study design, assay development, ICH analytical validation and project management. Experience in analytical techniques e.g. Elisa Neutralization assays, other in vitro cell based or in vivo Bioassays. Experience in immunology/immunogenicity studies. Ability to manage multiple studies. For more information, please call me on 091 507507 or email me at Annemarie.fox@cpl.ie