Emplois/Fellowship

Offres d'Emplois

Le Breast European Adjuvant Studies Team (Br.E.A.S.T.) de l'Institut

Jules Bordet engage

Clinical Study Manager

The BrEAST Data Centre from the Jules Bordet Institute is currently recruiting:

 
Clinical Study Manager

 

Core Skills:

The post holder will have a leading role in planning, co-ordinating and completing the project. He/she will need excellent communication, presentation skills and the ability to organise both him/herself and others. He/she will need to demonstrate flair and innovation when faced with challenges, excellent leadership skills and academic ability to fulfil the requirements of this job. He/she will contribute to the strategic direction of the trial as well as taking responsibility for the day-to day-management and will work closely with the Principal Investigator, Project Management Group and other bodies with vested interests to ensure the trial’s successful completion.

 

Expected responsibilities are outlined below:

External responsibilities:
• Maintain an up-to-date knowledge of the regulatory and governance requirements for clinical trials.
• Be responsible for communicating effectively with health care professionals, pharmaceutical partners, collaborative research groups, data management and administrative staff.
• Develop and maintain on-going interest in the trial among participating investigators, health care professionals, collaborative research groups and internal study team.
• Where applicable, produce regular progress, safety and annual reports for regulatory agencies, funding bodies and the sponsor(s).
• Assist with the preparation of progress reports for the Trial Steering and Data Monitoring Committees.
• Maintain a database of contacts with participating clinicians, health care professionals, and study partners.
• Ensure all trial procedures are developed according to Good Clinical Practice, Data Protection Guidelines, and relevant national and international government frameworks.
• Facilitate and participate in regular meetings (mostly teleconferences) with study partners.
• Assist with preparation of publications for relevant scientific journals.
• Where necessary, assist with international, national, local and special approvals required by the trial, its staff and the various participating sites.

 

Internal responsibilities:
• Responsible for ensuring that trial staff are trained in Good Clinical Practice and have the required training and/or experience to meet the international, national and local regulations.
• Contribute to the development of the trial protocol and facilitate the approvals and notification of any amendments.
• Responsible of resources planning for budgeting purposes and contract review.
• Develop essential trial specific guidelines and Standard Operating Procedures (SOPs).
• Ensure all members of the trial team are familiar with the trial guidelines and SOPs and work in compliance with them.
• Periodically review the practice within the trial team to ensure that the trial guidelines and SOPs are adhered to.
• Recruit, train, appraise and supervise the development of the trial team to ensure the successful completion of the trial.
• Where applicable, design, produce and distribute trial materials to participating research groups and/or sites.
• Establish trial procedures that ensure compliance with the protocol and monitor their effects regularly.
• Collaborate with data management and quality assurance team.
• Ensure that quality control procedures are in place for all aspects of the trial, e.g. version control and document histories
• Take overall responsibility for quality assurance by producing, with the trial statistician and trial programmer, specifications for central data monitoring and reporting.
• Ensure recruitment and retention are monitored and procedures are in place for dealing with any problems arising from any shortfall.
• Plus: responsible for ensuring that the trial has the relevant approvals and meets the required governance criteria.
 

Application

CV/written application must be sent by e-mail to gestion.oncomed@bordet.be