Experienced Clinical Trial Assistant/ eTMF specialist

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!

Job Description 

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.

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.

Profile 

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

Contact Information 

Ellie Depape
+32 15 21 11 04
Ellie.depape@valesta.com

Application form : Experienced Clinical Trial Assistant/ eTMF specialist

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
Please read our disclaimer.