Senior Clinical Trial Assistant

il y a 1 semaine

Bruxelles, Région de Bruxelles, Belgique SolCur Temps plein

We are looking for a driven and ambitious colleague that will be responsible for administrative, logistics and operational support to the Clinical Operation team. This position will function under the guidance and direction of the Head of Clinical Operations. The successful candidate will be autonomous and proactive with experience in working in a clinical environment.

Main activities are:

  • Assist Clinical Trial Managers (CTM) with the administration, coordination, and archiving of assigned clinical trials (e.g., CTMS build and tracking, v-TMF build & upload).
  • Track and ensure the completeness of study essential documents in the Trial Master File, adhering to regulations and guidelines.
  • Creation/distribution of Investigator Site File (ISF) binders.
  • Assist study staff and investigators in resolving issues related to the Trial Master File (TMF) and Investigator Site File (ISF), including implementing corrective and preventive actions.
  • Facilitate internal communication of critical clinical data and events.
  • Provide safety documentation to support safety committee meetings as requested.
  • Assist with logistics, device tracking and ordering if required and if applicable.
  • Participate in process improvement activities related to CTMS and v-TMF within the department.
  • Collaborate with the CTM to develop and adapt trial documents to specific requirements.
  • Organize trial-specific meetings, including agenda preparation, meeting minutes, and follow-up on action items.

In addition to the responsibilities above, the senior CTA can also assist in the following tasks:

  • May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders.

Qualifications:

  • Minimum of 5 years of experience in a similar position within Clinical Operations.
  • Written and spoken fluency in Dutch and/or English.
  • Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials.
  • Clinical Trial experience.
  • (v)TMF experience.
  • Proficient in software applications such as Outlook, Word, Excel and PowerPoint.
  • Demonstrated competencies in the following areas are required: Tracking, Written and verbal communications, Attention to details, Organizational skills.

What we offer:

✓ We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charge pass, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included).

✓ We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...).

✓ Side activities will be organised regularly, to achieve a close collaboration within our team.

✓ We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.

✓ We contribute to a number of charities & support the research and/or the patients in our industry.

Still have questions? Please drop us a line.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

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