Clinical Trial Coordinator, BelgiuminVentiv Health Clinical
Clinical Trial Coordinator, Belgium
Clinical Trial Coordinator, Belgium
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
For our client, a global pharmaceutical organization we are currently looking for a Protocol Specialist . In this full time role you will be working from the Client’s office in Braine L’Alleud, but you are allowed to work from home one day per week once you are fully trained.
The Protocol Specialist managesprogram related deliverables critical to start-up, maintenance and closure for Phase I-IV protocols. The role is focused on global project and program level.
Typical activities of the Protocol Specialist include:
Manages the execution and setup of Data Monitoring Committee’s, Independent Review Committee, adjudication process and vendor set-up.
Responsible for Investigator Meeting planning and execution.
Manage country planning and protocol level milestones and drivers in Eclipse.
Collaborates with the Protocol Manager to ensure complete review of protocol level listings as outlined in the data review plan.
Responsible for process/stakeholder management for MDO study set up and execution (e.g., project tracking, vendor set up, cost plan requests and invoice tracking)
Manages the development and/or collection of study level documentation.
Manages the global setup of study level non-clinical supplies.
Manage vendor communication and resolves query related issues.
Bachelor’s degree in nursing, life science or healthcare related field.
1-3 years’ experience in Clinical Research or related work experience
Knowledge of ICH/GCP Guidelines and local regulatory guidelines or regulations preferred.
Experience in the use of industry Clinical Trial Management Systems, Clinical Trial Master File Systems and Data Management Systems preferred
Proficient in Microsoft Word, Excel and PowerPoint
Fluent in English
Europe - Belgium Client Based
Europe - Belgium Regional
INC Research/inVentiv Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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inVentiv Health Clinical was launched in January 2013 as the clinical segment of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value. With roots dating back to 1984, inVentiv Health Clinical is an amalgamation of a number of clinical services companies who, when brought together, had the skills and experience to allow inVentiv Health Clinical to become a leading global Clinical Research Organization.