For our client located in Merksem, we are looking for a Lab Coordinator/Scientist .
You will be a member of the study team that is focusing on the safe and efficient execution of clinical studies for all activities related to Lab. You are responsible for the analytical and logistical organization and execution of all operational activities and procedures, i.e. biomarker assay implementation, calibration, and validation, dependent on the qualification and validation processes. You provide high-quality study data in accordance with the Unit’s Standard Operating Procedures and Work Instructions and operate in line with ICH-GCP guidelines, ISO 15189 for Medical Laboratories, and national legislations.
- You are taking care of the study Preparation and provide input to laboratory-related parts of study protocols
- You ensure detailed preparation for trial execution with respect to materials and methods, the preparation of written instructions for Laboratory Technicians, Clinical Research Coordinators (CRCs), and Trial Nurses, and the timely ordering and management of the required materials and equipment
- You actively working on process improvements initiatives for the laboratory
- You keep all Laboratory related equipment in excellent working condition by timely maintenance and calibration
- You oversee effective and efficient setup in the system in agreement with internal and external (e.g. Data Management) requirements
- You will execute laboratory tasks regarding the processing of pharmacokinetic, pharmacodynamic, clinical chemistry, and other (biomarker) samples, and of specific assays on site
- You will train your colleagues for the tasks involved and coordinates their work
- You supervise the group and take care of the planning and distribution of the work between the available laboratory technicians and other personnel authorized for the execution of laboratory-related tasks
- You prepare and execute worldwide shipments of samples in line with the International regulations
- You have a Master/PhD in Pharmaceutical or Biomedical Sciences or an advanced degree in Lifesciences.
- Relevant working experience in a Clinical Chemistry laboratory or phase I unit is an asset
- Good working knowledge of the ICH-GCP guidelines and/or other relevant regulations and regulatory guidelines is an advantage
- You have the ability to handle projects and to organize and prioritize your work as such that goals are being met.
- You are Fluent in English and have a Proficiency in Dutch
- Strong knowledge and understanding of the application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required
- Strong written, verbal, and interpersonal communication skills
- You are pro-active and creative in identifying and solving problems
- You are able to cope with administrative tasks and stressful situations
- Able to establish and maintain effective working relationships
- Good accuracy, structural approach, and attention to detail