Reference: 09/2017
Number of vacancies: 1
Offer description:
Background: Quality Assurance ensures that a product or service meets the established standards of quality including reliability, usability, and performance. VHIO's Clinical Research Program, incorporating multidisciplinary cancer teams, is dedicated to developing both novel agents directed to specific signaling pathways in cancer and novel/redefined tools to diagnose cancer earlier and better predict response to therapy. We pioneer important studies involving both preclinical and early-drug development research studies and lead several phase I, II, and III clinical trials designed to identify more effective cancer therapies tailored to individual patients.
Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. To guarantee accuracy and integrity of clinical data, it is necessary to thoroughly review these data, assess the validity of outlying data points, and carefully document query identification and resolution throughout a study's duration. Maintaining accuracy and quality throughout a clinical trial is a continual, dynamic process. Although study requirements are carefully outlined initially in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during a study. This ongoing process requires revising mechanisms and communicating these revisions clearly to all investigators and support staff.
Requirements (degree, experience, additional training):
We seek:
Key Competencies: The following competencies will also be favorably considered:
Attention to detailGood verbal and written communicatorData collection and managementExcellent analytical skills with the ability to problem solve and take decisionsGood planning and organizational skillsCustomer service orientedTeam playerMain Roles and Responsibilities:
Draft quality assurance policies and proceduresInterpretation and implementation of quality assurance standardsEvaluate adequacy of quality assurance standardsDevise sampling procedures and indications for recording and reporting quality dataReview the implementation and efficiency of quality and inspection systemsPlan, conduct and monitor testing and inspection of materials and products to ensure finished product qualityDocument internal audits and other quality assurance activitiesInvestigate customer complaints and non-conformance issuesCollect and compile statistical quality dataAnalyze data to identify areas for improvement in the quality systemDevelop, recommend and monitor corrective and preventive actionsPrepare reports to communicate outcomes of quality activitiesIdentify training needs and organize training interventions to meet quality standardsCoordinate and support on-site audits conducted by external providersEvaluate audit findings and implement appropriate corrective actionsMonitor risk management activitiesManage document management systemsGuarantee ongoing compliance with quality and industry regulatory requirementsAdditional Information:
Established in 2006, the Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain, is a leading comprehensive cancer center of excellence where its researchers and physician-scientists adopt a purely translational research model, working together as multidisciplinary teams to both accelerate and advance personalized and targeted therapies against cancer. Undertaking one of Spain's most dynamic cancer research programs, VHIO is dedicated to delivering on the promise of precision medicine in oncology - turning cancer discovery into more effective, tailored treatments and better practice for the care of our patients.
VHIO Provides: A dynamic, multidisciplinary research environment, optimal laboratory space and access to our cutting-edge core technologies: Cancer Genomics, Molecular Oncology, Translational Genomics, and Proteomics which are not only responsible for the development of VHIO's core technologies and platforms but also pursue, implement and develop their own independent research lines and projects.
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