| 23 December 2009 | ||
| GLOBAL STUDY MANAGER | ||
|
Company Description:
The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently recruiting for an R&D Planner to work for a Global leading Biological company in Belgium. This role is based at their office in Rixensart and would initially be a 6 month contract. Function summary: . Management of all types of studies (Phase I to Phase IV, 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 . Acting 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 . Analysis and evaluation of the feasibility and consequences of design proposed in regards to procedures, consultation of other departments (double blind lots…), other teams (DM, …) and with the countries for the monitoring. Ensuring that the 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 supply request, report) . Proposal, organization and lead of monitors meeting, to transfer knowledge and study specific training in order to ensure the highest quality standards. Assessment of need for and proposal of co-monitoring visits in countries or do co-monitoring upon request . Delegation of work to CTA and/or Global Study Coordinators of his/her project and coach him/her depending on expertise . Active participation and representation of 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. Funtion Description: Other Requirements: Education: . Master degree in Sciences Knowledge: . Good knowledge and understanding of Global Study Management roles and activities . Good knowledge of ICH-GCP . Knowledge of Regional organization and understanding of Local Operating Countries structure . Basic knowledge of project vaccine, CDP, Target Product Profile for her/his project . Excellent knowledge of written & spoken English, knowledge of French is an asset . Good communication skills . Team spirit . Well organized . Independent worker . Stress resistant . Motivated and dynamic personality . Proactive . Familiar with electronic tools like Microsoft Word, Excel, PowerPoint, … Experience: . At least 2 years experience in clinical trials environment as CRA/monitor or equivalent experience . Monitoring experience Offer: . Full-time, permanent contract Work location: . Rixensart, Wallonia To apply, please send your CV to nicky.cooke@chiltern.com | ||
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