Job : Glaxo Smith Kline : Study Manager

Job Title             : Global Study Manager
Company Name : Glaxo Smith Kline
Locations            : Bangalore, India
Qualification and requirement :  

• University degree / Post-graduate degree in biological sciences, Genetics, Biotechnology, Microbiology etc.
• At least 5 years experience in clinical trials environment as clinical monitor or clinical research associate or clinical research manager (with monitoring experience)
• Good knowledge and understanding of Study Management roles and activities
• Good knowledge and experience of having used project management tools.
• Strong knowledge ICH-GCP.
• Excellent knowledge of written & spoken English. Additionally knowledge of French is desirable.
• Basic knowledge of project vaccine, Clinical development plan, Target Product Profile for her/his project

Responsibility :

•  The role will focus on evaluation of safety and effectiveness of the drug. Includes Phases I to IV. Some roles might demand patient interaction while others are limited to consulting, benchwork and analysis. The primary responsibilities include the design, planning, organization, analysis and evaluation of studies during clinical trials. Key responsibilities include:
• Managing all types of studies (Phase I to Phase III, standard or non-standard project, collaborative, multi country) 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 regard to procedures, consult other departments (double blind lots…), other teams (DM, …) 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 (protocol, CRF, ICF, primary SR, report)
• 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 Assistant and/or Global Study Coordinators 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, Investigator/monitors meeting

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