Clinical Data Monitor

Reference: HAR-16-014

Client

Our client is a global top 10 pharma company located at the east side of Antwerp.

This function is office based.

Main purpose

The Clinical Data Monitor is responsible for the Client’s Diagnostics related projects (CDx).

Tasks

  • Participates actively in the start-up of CDx:
    • Interacts daily with clients and makes sure all operational agreements are made in correlation with client requirements.
    • Ensures clear and correct understanding of the project description, clinical trial protocol and SOW.
    • Is responsible for the full operational set-up of dedicated Client’s Infectious Diseases projects.
    • Sets up the related project master files for administration.
    • Contributes in the set-up and monitoring of new research assays.
    • Ensures adequate communication with the data manager.
    • Ensures adequate communication with Sample Reception for the preparation of new assigned CDx’s.

 

  • Monitors the assigned CDx:
    • First point of contact for all CDx and maintains client satisfaction.
    • Is responsible for the initiation of Work orders and makes sure all RUO samples are started in our lab process, according to client agreements.
    • Works closely with the lab to continuously align lab capacity with client expectations & priority settings.
    • Resolves project related queries/ complaints to ensure adequate follow-up of actions.
    • Prepares status reports, give feedback to manager project coordination.
    • Performs data checks to ensure data quality and accuracy.
    • Acts as back-up for database transfers in absence of data manager.
    • Prepares invoicing and liaises with Finance department regarding agreed contract specs.

 

  • Ensures adequate follow-up and closure of CDx:

    • Performs final Quality control checks on database transfers for final lock.
    • Reviews filing of documentation for completeness in the appropriate binders.
    • Ensures final invoicing.

 

  • General Project management tasks

    • Keeps track of timelines of projects.
    • Reports issues related to the services offered to Hierarchical Supervisor.
    • Can be nominated as team member of a new project.
    • Writes and reviews Standard Operating Procedures, Work Instructions and Form Controlled Documents.
    • Creates KPI overviews for evaluation.
    • Ensures confidentiality of patient related information

 

  • Departmental tasks

    • Ensures effective communication within the department.
    • Participates in meetings / writes meeting minutes
    • Responsible for training of back-up personnel

Requirements

  • University degree – medical or paramedical (pharmacy, biology, engineer in technical disciplines, or other scientific degree or equivalent by work experience).
  • Basic Laboratory experience on the field
  • Experience in Quality Systems
  • Familiar with Clinical Trials
  • Knowledge of GCP requirements
  • Outstanding written and oral communication skills in English
  • Computer knowledge
  • Project management skills
  • People management skills
  • Communication skills

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