Site Management Associate Leuven (BE) • Oxford Global Resources

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Are you excited to start your career in Clinical Research? Do you want to be part of a growing, dynamic, global company with a very nice familial team spirit? Don't hesitate and apply now!

Job Description

As a Site Management Associate you will be performingnon-monitoring site management activities, providing project administrative support, managing documents, project-specific trackers and maintaining communication with the sites, study vendors and members of the project team. You will be operating at site and country level.

Responsibilities

• Site Management
• Ensures exchange of information and documentation with sites and vendors
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Ensures regulatory and ethics committee submissions and notifications
• Ensures proper administration of sites and vendors payments
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
• Reviews and coordinates site-specific query resolution
• Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status
• Other Communication
• Exchanges information and documentation with other departments
• Supports the organization of internal team meetings including preparation of agendas and minutes
• Supports the organization of Investigator Meetings
• Maintains study-specific and corporate tracking systems
• Serves as the sites' primary contact point
• Serves as the primary sites' contact point for vendors, study supplies, and access management
• Ensures communication between the sites and off-site facilities
• Training
• Arranges and tracks initial and on-going project training for site teams in all vendor-related systems
• Provides training in courier management and study supplies ordering to the site team
• Document Management
• Checks the TMF on a site and a country level regularly and files pending documents
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
• Revises and checks translations status
• Vendor Management
• Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
• Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level
• CTMS Management
• Updates CTMS with lacking project information
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
• Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS
• Tracks the resolution status of site issues and action items in CTMS
• Safety Management
• Ensures proper safety information flow with investigative sites
• Other departmental assignments, as necessary

  Requirements

  • College or University Degree or an equivalent combination of education, training and experience
  • A first experience in the industry or in clinical research is a strong asset
  • Full working proficiency in Dutch and English
  • Basic knowledge of French
  • PC skills to be able to work with MS Word, Excel and PowerPoint
  • Ability to plan, multitask and work in a dynamic team environment
  • Excellent communication and collaboration skills

  Benefits

  • Salary package based on experience
  • Hybrid policy : 2 days in the office in Leuven, 3 days homeworking
  • 1 year as an Oxford consultant followed by a fixed client contract

  Vacancy number: 26018