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Local Trial Manager

Solliciteer hier

Aline Vandermeeren
Business Unit Manager


Solliciteer hier

Aline Vandermeeren
Business Unit Manager



Aline Vandermeeren
Business Unit Manager
+32 497 71 58 10


Jobomschrijving

An LTM is nominated on country (OPU) level and works within the Clinical Operations Division of MIDI (ROPU). The LTM works in close collaboration with the COL, Clinical Trial Manager (CTM) and the CRO-Clinical Research Associate (CRA)for the implementation and management of one or more clinical trial(s) in their OPU.

  • Perform OPU and site feasibility/selection within the defined timelines by identifying (academic) networks, External Experts and top recruiting sites in close collaboration with Medical Affairs and the Clinical Operations Lead 
  • Accountable for the start-up activities on local level ensuring that allocated trials are started within the defined timelines 
  • Accountable for set-up and management of trial budget on OPU level, including making updates based on financial reports in close collaboration with CTM
  • Participate in appropriate study trial team meetings to report the status on start–up progress and align on recruitment strategies and action plans with the CRO-CRA, CTM, COL and Medical Affairs to ensure predefined study targets are met
  • Represents the Clinops team in both internal and external communication and plays a site relation management role on OPU level during feasibility process and the entire duration of the trial. 
  • Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices and regulatory requirements. 

Profiel

  • Degree in Life Sciences
  • First experience within Clinical Research (CT Submission, contract negotiation, ..) 
  • Fluent in French, Dutch and English
  • Good knowledge in processes in place related to submission packages of trials to EC/CA
  • Team player and good communicator
  • Flexible, agile and quick learner
  • Project management & problem solving skills
  • Customer focused activities
  • Results oriented

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Contactgegevens

Opleiding en ervaring

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+32 497 71 58 10