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Personnel Training of Good Clinical Practices Inspection Unit

Region
North Africa
Country
Turkey
Duration in month
11 - 22 days
Start date
January 2016
End date
November 2016
Project description
The global objective is to improve the GCP Inspection standards currently applicable in Turkey and to harmonize the activities of the Inspectorate of Turkish Medicine and Medical Device Agency with the relevant EU practices.

Four training sessions shall be delivered in Turkey.
 

Team Leader- Phase I Clinical Trials Expert

Skills
Medicines and pharmaceutical policies
duration
Short term
End recruitment
27/11/2015
Job qualification
Qualifications and skills
• At least Master’s degree in pharmaceutical and/or medicinal sciences or relevant fields. In the absence of the degree requested, the expert will have an equivalent professional experience of minimum 17 years in the relevant fields.
• Good command of spoken and written English.

General Professional Experience
• Minimum 12 years of experience in the sector(s) related to the lot.

Specific Professional Experience
• Experience as a senior CRA (Clinical Research Associate) in at least 3 Phase I, II or III clinical trials (At least one of the experiences should be in Phase I clinical trial.)
• At least 3 years of experience in auditing of Phase I, II or III clinical trials.
• Experience in design or delivery of at least one GCP training.
• Experience in clinical project management in Phase I or II or III clinical trials will be an asset.
Mission duration and start date
22 working days
C.V. model
 

Expert 2 : Bioavailability (BA) / Bioequivalence (BE) Studies Expert

Skills
Other
duration
Short term
End recruitment
27/11/2015
Job qualification
Qualifications and skills
• At least Master’s degree in pharmaceutical and/or medicinal sciences or relevant fields. In the absence of the degree requested, the expert will have an equivalent professional experience of minimum 17 years in the relevant fields.
• Good command of spoken and written English.

General Professional Experience
• Minimum 12 years of experience in the sector(s) related to the lot.

Specific Professional Experience
• At least 2 experiences of auditing of BA and/or BE studies.
• Experience in project management in BA and/or BE studies will be an asset.
Mission duration and start date
17 working days
C.V. model
 

Expert 3 : Phase II, Phase III, Phase IV, CRO and Sponsor Inspections

Skills
Other
duration
Short term
End recruitment
27/11/2015
Job qualification
Qualifications and skills
• At least Master’s degree in pharmaceutical and/or medicinal sciences or relevant fields. In the absence of the degree requested, the expert will have an equivalent professional experience of minimum 11 years in the relevant fields.
• Good command of spoken and written English.

General Professional Experience
• Minimum 6 years of experience in the sector(s) related to the lot.

Specific Professional Experience
• Experience as a CRA (Clinical Research Associate) in at least 2 Phase I, II or III clinical trials.
• Experience of design or delivery of at least one GCP training.
• Experience in clinical project management in Phase I, II or III clinical trials will be an asset.
Mission duration and start date
11 working days
C.V. model
 
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