Clinical Data Monitor
Our client is a global top 10 pharma company located at the east side of Antwerp.
This function is office based.
The Clinical Data Monitor is responsible for the Client’s Diagnostics related projects (CDx).
- 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
- 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