Feb 192018

For one of our leading clients in the region of Zaventem we are looking for a CTA/ eTMF specialist

  • Do you have a first experience as a Clinical Trial Assistant?

  • Are you proficient in working with TMF?

  • Do you have a good knowledge of English and looking for a job opportunity in an international work environment?

       Then don’t hesitate to find out more about this interesting opportunity!

As a Clinical Trial Assistant (CTA) you are part of a clinical trial team and responsible for the administrative support during the startup, execution and closing of clinical studies. You have a wide variety of tasks and responsibilities.

  • You provide general support to the study staff within the Clinical Operations Team and effectively resolve issues related to the Study Files (Trial Master File and Investigator Site File).
  • You support the project managers within the assigned clinical studies.

  • You are accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.

  • You respond to possible clinical trial related problems and assist in implementing corrective and preventive actions.

  • You are responsible for the creation and distribution of the regulatory binders & signed documents binder

  • You assist in providing internal communications of important clinical data and events.

  • You support ongoing use of Clinical Trial Management System (CTMS) by maintaining and tracking relevant activities.

  • You provide safety documentation to other functional groups in support of safety committee meetings as requested.

  • You give assistance with logistics for Investigator meetings/expert panel meetings.

  • You participate in process improvement activities related to CTMS/v-TMF within the department.

  • You may be asked to assist with device tracking and ordering if required.

Education background and soft skills:

  • Minimum of a Bachelor’s Degree is required (clinical/life science background is a plus).

  • A first experience in the pharmaceutical industry is required, TMF experience is a must.

  • You have knowledge of working with computer systems (Microsoft office – Excel, Word and Power Point).

  • You are fluent in English (written and verbal communications), a good knowledge of French or Dutch is an asset.

  • You have interest in learning and can work autonomously

  • You are well-organized and rigorous with excellent attention to details

  • You are able to work in a multitasking environment

  • You are team-oriented

Valesta offers

a flexible working environment
a personal career guidance
an attractive salary with additional benefits, completely in line with your function and experience

Match criteria: Medical Practice, Research, Researcher, Health Care Provider, Quality Assurance, Neuroscientist, 40 hours, Outside the Netherlands, Non

Company name: Stepstone NL –

click here for more details and apply to position

Tipical Questions
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Questions to ask
What can you tell me about your new products or plans for growth? This question should be customized for your particular needs. Do your homework on the employer’s site beforehand and mention a new product or service it’s launching to demonstrate your research and interest. The answer to the question will give you a good idea of where the employer is headed.