Project Lead – clinical study
Hainaut – CDI
#project #clinicalstudy #GLP #method #validation #assay #training
Are you interested in the biotechnology and putting your knowledge of clinical study to good use?
Our client is actively looking for a Project Leader to strengthen its activities. Our partner is active in the pharmaceutical sector.
What are your responsibilities?
As Project Leader – clinical study, you are in charge to
- Management of method validation, assay transfer and sample analysis studies;
- Prepares and/or reviews worksheets related to studies;
- Ensures personnel are trained and training appropriately documented;
- Ensures high level documents are signed and acknowledged by personnel involved in the study;
- Ensures study binders are up to date;
- Follows up on assigned study inventory and sample manifest;
- Follows up on deviations ;
- Follows up on QC review and ensures it is performed in a timely fashion;
- Prepares and/or reviews of data tabulation and study related documents;
- Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates; coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
- Submits studies to QA and answers to QA reports;
- Schedules experiments based on the timelines, priorities and requirements;
- Writes and reviews method SOP/CSP;
- Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
- Performs other duties as assigned;
- Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies.
Who are you?
You are graduated as a Master degree in Life Sciences, preferably in Immunology. You have a minimum of 2 years of experience in similar position, in biotechnology. You have a good knowledge of clinical study conduct, a good knowledge and understanding of bioanalytical method validation guidelines and requirements. Also, you have knowledge and understanding of GLP, GCLP regulations to carry out GLP studies. You demonstrate knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines. You fluently speak English. Your soft skills are Strong quality mindset, strong cross-functional communication skills, capable of producing document of high quality, rigorous and autonomous in the conduct of their work, effective organizational skills and flexibility and ability to lead a study.
Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
Employee is personally responsible for following Health and Safety guidelines/instructions. This position can involve evening and/or week-end work.
What can you expect?
A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.
You’re interested in this job? We kindly invite you to apply directly on our website experis.be. Do you have questions? You can contact Dimitri Soupart : [email protected]