Site Management Associate

Oxford Global Resources; Vlaams-Brabant; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Salary package based on experience

Hybrid policy: 2 days in the office, 3 days homeworking

1 year as an Oxford consultant followed by a fixed client contract

Résumé du poste

Oxford Global Resources is seeking a Site Management Associate in Belgium, Vlaams-Brabant. This role involves performing non-monitoring site management activities, providing project administrative support, and managing documentation. You will ensure communication with sites, vendors, and project team members while coordinating various site management tasks.

The ideal candidate will possess a College or University degree, full proficiency in Dutch and English, and have strong skills in multitasking and communication. This position offers a hybrid work model with 2 days in the office and 3 days remote.

Qualifications

• A first experience in clinical research is a strong asset.
• Ability to plan, multitask and work in a dynamic team environment.

Responsabilités

• Ensures regulatory and ethics committee submissions and notifications.
• Coordinates preparation for and follow-up on audits and inspections.
• Maintains communication between the sites and off-site facilities.

Connaissances

Full working proficiency in Dutch

Full working proficiency in English

Basic knowledge of French

Excellent communication skills

PC skills (MS Word, Excel, PowerPoint)

Formation

College or University Degree

Description du poste

Job Description

As a Site Management Associate you will be performing non-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