Organisation/Company: IDIVALDepartment: Human Resources DepartmentResearch Field: Medical sciences » Health sciencesResearcher Profile: Recognised Researcher (R2)Positions: Bachelor PositionsCountry: SpainApplication Deadline: 19 Dec 2024 - 23:59 (Europe/Brussels)Type of Contract: PermanentJob Status: Full-timeHours Per Week: 35Offer Starting Date: 10 Dec 2024Is the job funded through the EU Research Framework Programme? Not funded by a EU programmeIs the Job related to staff position within a Research Infrastructure? NoOffer DescriptionACADEMIC DEGREE: Degree in Biology/Equivalent (Justification must be provided with the application).FUNCTIONS:Responsible for the overall management of clinical trials from start to finish (suitability of the site, recruitment, schedules, sample and medication management, records, etc.).Ensure compliance with applicable legislation, Good Clinical Practice and ICH Guidelines.Coordinate all trial activities, including management of internal teams and communication with promoters and CROs.The position requires strong leadership analytical skills to manage deadlines and solve problems.Overall responsibility for delivering projects on time.Coordinate the meetings of the research team and act as the main point of contact with the sponsor/CRO.Create and control project schedules.Coordinate study suppliers (e.g., EDC, clinical supplies, medication shipments).Supervise the trial start-up procedures (documentation of the research team, contracts with sponsors, IMS).Review protocols and other important study documents.Monitor activities in communication with CRAs, as well as sponsor audits and inspections of regulatory agencies.Work in collaboration with other services and centres involved in the research project.VALUED MERITS /SKILLS:General knowledge of ERC.Title of expert or specialist in Project Management in Clinical Research.EXPERIENCE:Experience in resource planning, budgeting and quality management of research projects.Experience in monitoring and coordination of ECCE (phases I to IV).Previous experience in research groups.LANGUAGES: English, Level B2 - C1.OTHERS:Management of medical databases and documentation archives.Management of clinical research management software tools (EDC, CTMS...).Handling and sending biological samples and accounting for drugs in research.Specific Requirements:EXCLUSIVE REQUIREMENTS:ACADEMIC DEGREE: Degree in Biology/Equivalent (Justification must be provided with the application).EXPERIENCE: Experience in clinical research (Justification must be provided with the application).OTHERS REQUIREMENTS: Certificate of Good Clinical Practice (Justification must be provided with the application).Additional InformationANNUAL GROSS SALARY: 23.448,41€ without prejudice to the basic update established in state legislation for 2024Eligibility criteriaVALUATION OF MERITS:General knowledge of ERC - MAXIMUM 5Title of expert or specialist in Project Management in Clinical Research - MAXIMUM 10Experience in resource planning, budgeting and quality management of research projects - MAXIMUM 10Experience in monitoring and coordination of ECCE (phases I to IV) - MAXIMUM 10Previous experience in research groups - MAXIMUM 10English - MAXIMUM 5Management of medical databases and documentation archives - MAXIMUM 10Management of clinical research management software tools (EDC, CTMS...) - MAXIMUM 10Handling and sending biological samples and accounting for drugs in research - MAXIMUM 10Selection processSELECTION PROCESS STAGES:Admission of applications.Competition phase.Interview phase: maximum number of candidates to be interviewed: 3. Minimum score for this phase: 50.Report of the Tribunal.Resolution.Note: in order for candidates to be considered for recruitment and employment exchange purposes, they must have a total score of at least 30 points.SELECTION BOARD:President: Dr. Emilio Rodrigo Calabia, Principal Research.Member: Dr. Juan Carlos Ruiz San Millán, Research.Member and secretary: Maria José Marín Vidalled, Coordinator of IDIVAL Technological Services.
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