Intern, Clinical Data Coordinator / Stagiaire, Coordinateur des données cliniqu

Description*** Please note that this is a summer internship (June to August) *** The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.This role will be perfect for you if: You have strong analytical capacities and an ease to work with data.You enjoy working with systems and technology, continuously learning.You want to work in a collaborative team where your ideas are heard and valued.RESPONSIBILITIES-Provides general data management support to the project team, sponsor and external vendors, as needed.-Supports Lead Data Manager in the areas of:Data Review.Data Reconciliation.Discrepancy Management.Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.Generation of Ad-Hoc Study Reports.User Maintenance.Assisting with User Acceptance Testing.Assisting with designing of database.Assisting with creating data management plan (DMP), and other clinical data management related documentation.Assisting in ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).RequirementsIDEAL PROFILEEducation B.Sc. or related field;Experience 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset;Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.Knowledge and skillsSkilled in use of computer technology, and ability to learn new applications;A general knowledge of CDASH/SDTM is considered an assetHighly organized and detail-oriented with effective project planning and time management skills;Strong verbal and written communication skills in English, French is an asset;Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands;Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.Our companyAbout Indero A Global Clinical Leader In Dermatology!Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.Innovaderm only accepts applicants who can legally work in Canada.Description de poste*** Veuillez noter qu'il s'agit d'un stage d'été (de juin à août) *** Le coordonnateur de données cliniques participera à diverses activités de gestion des données cliniques requises pour s'assurer que les données recueillies dans le cadre des essais cliniques entrepris ou gérés par Innovaderm sont recueillies, gérées et rapportées de façon claire, précise et sécurisée. De plus, il est requis pour ce poste de mener toutes ces activités conformément aux exigences réglementaires applicables, aux lignes directrices de l'industrie et aux procédures d’exploitation normalisées (SOP) d'Innovaderm tout en respectant l'engagement d'Innovaderm envers les exigences et les échéanciers du client.Ce poste sera parfait pour vous si : Vous avez de fortes capacités d’analyse et une facilité à travailler avec des données.Vous aimez travailler avec des systèmes informatiqu