Study Director
Summary This position is based in Madrid, Spain and is open to local and international applications. As a study director you will be responsible for the design, planning, execution, and final report of pre-clinical studies, ensuring GLP compliance throughout the studies. Due to the global client-base, all candidates require English language abilities plus Spanish, Italian, or Portuguese combined with experience of pre-clinical / non-clinical studies. This is an exciting time to join the business which has doubled in size in the past four years. The company supports its staff including encouraging internal promotion into new roles and ongoing training. The company The company is a specialist Contract Research Organisation (CRO) with a friendly and caring culture, and which is investing heavily in its people, equipment, systems, staff, and employee benefits. This CRO is continuing to win new clients from all over the globe, supporting the development of new and safe drugs and treatments. The culture is describe as caring, supportive and youthful and with a “good atmosphere”. The opportunity You will oversee the progress of a study. Your task will be:
Approve the study plan which is prepared before study initiation by dated signature. This document should clearly define the objectives and the whole conduct of the study and how they are to be achieved. Any amendments to the study plan have to be approved as mentioned above Report to the study monitor / sponsor on the condition of the study plan. Coordinate with the delegated phases the deadlines for the reports. Follow the indications of the quality assurance unit. Train and involve to the staff of a study in the aims of the same one and critical points of bearing in mind. Ensuring that all staff are clearly aware of the requirements of the study and should ensure that the study plan and amendments are available to all relevant personnel. Ask for training to the Operational director if training is needed. Elaborate laboratory notebooks Before the experimental starting date of the study, the Study Director should ensure that copies of the study plan or amendments are supplied to all personnel involved in the study; this should include Quality Assurance (QA). Ensure and coordinate the enough stock material resources for the execution of the study. The study director may delegate to the responsible technician the following tasks:
Identification and request critical and or specific material for the study. Assure availability of necessary materials in time for the correct execution of the procedures. Elaborate the laboratory notebooks except formulation laboratory notebook that must be elaborated by study director. The laboratory notebook should be supervised, signed and dated by study director. For GLP studies, the laboratory notebook should be signed by Quality Assurance Unit. Supervise that, during the execution of the study, the procedure carry out as described in the SOP in place. Supervise that the study carries out as planned in dates, schedule and personnel involved in the study. The responsible technician should notify the study director if any change takes place. You will elaborate the final report. The final report of a study should be elaborated as a detailed scientific document outlining the purpose of the study, describing the methods and materials used, summarizing and analysing data generated, and stating the conclusions drawn. You will collaborate with the study monitor and the Quality Assurance Unit The candidate
Degree in Life Sciences Experience of pre-clinical / non-clinical studies Experience at study director level or aspiring to become a study director Experience working to GLP standards Experience in pharmacology and toxicology Experience with pharmacokinetics, clinical analysis, clinical observations Upholding the highest standards of animal welfare Languages: English and Spanish and/or Italian and/or Portuguese Benefits
Bonus (15% of salary) Work from home (hybrid) Healthcare insurance Professional coaching External physiotherapist Good work life balance events, activities, wellness Additional flexible benefits under consideration for implementation in the coming months To explore this job opportunity further, please apply now or contact Wentworth Life Sciences to learn more about this exciting career move. ]]>
Fecha de publicación: 09/06/2022
