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Apply online for the
Global Study Manager
position and advance your career in the
Pharmaceutical industry today.
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Global Study Manager : GlaxoSmithKline
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| Job Number |
55564 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
10/8/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Clinical |
| Relocation |
Not Required |
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| Apply online at company website |
| Description |
Basic Qualification
Education
University degree in sciences or equivalent background
Experience
-At least 5 years experience in clinical trials environment
-Monitoring experience in an asset
Details
•Manage all types of studies according to ICH GCP guidelines and GSK policies and SOP’s to ensure the quality of the study data in order to use them in registration dossiers submissions to regulatory authorities.
•Act as the reference person for all operational/monitoring related issues for his/her studies between the central functions and the local actors of the studies and coordinates the operational aspects of a clinical study from start to end
•Analyze and evaluate the feasibility and consequences of design proposed in regards to procedures, consult other departments , other teams and with the countries for the monitoring. Ensure necessary specific user-guide is prepared on time (CRF completion guidelines, manual cleaning guidelines, Investigator laboratory manual...). Sign-off of essential documents
•Propose, organize and lead monitors meeting, to transfer knowledge and study specific training in order to ensure the highest quality standards. Assess need for and propose co-monitoring visits in countries or do co-monitoring upon request.
•Delegate work to Clinical Trial Assistent of his/her project and coach him/her depending on expertise.
•Actively participate and represent the Global Study Management function, taking into account the need of peers/other projects, in internal process improvements as well as training on their specific taskforce, including presentations at GSM meeting, workshop, SOP session, Inv/monitors meeting |
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| Requirements |
Preferred Qualification
-Good knowledge and understanding of Global Study Management roles and activites
-Good knowledge ICH-GCP.
-Excellent knowledge of written & spoken English, Knowledge of French is an asset. |
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| Contact Info |
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