Project Manager, Early Phase and Translational Research / …, Montreal

The Project Manager, EPTR ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects. In addition, the Project Manager, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables the trials. The Project Manager I, EPTR must ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Director, EPTR. This role will be perfect for you if: We can count on you to deliver results while using a disciplined approach to project management. You are looking for the next career step to prepare you to become a project manager. You are knowledgeable about clinical research projects and looking to continue learning. Working in an organization that is driven by science and innovation and completing meaningful work is important to you. More specifically, the Project Manager, EPTR: May serve as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study. Depending on the scope of the study, may lead the project. Coordinates tasks and deadlines between the different departments involved in the project. Oversees project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members Interacts with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines Escalates to project manager when site activation timelines are at risk or cannot be maintained. Assists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders. Assists with ensuring all team members are adequately trained on the project. May plan the activities and resources (e.g. internal and external resources, equipment, etc.) required for the project. Manages the quality of assigned work and deliverables Assists with providing project status updates to external and internal stakeholders Ensures assigned tasks are completed in compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Reconciles study trackers Assists with analyzing discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed. Assists with enforcing effective change control and risk management throughout the project. Reviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.). Assists with ensuring that study specific documents and project deliverables (e.g., protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements. Oversee activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits) Monitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan. Participates in the planning and conduct of Investigators Meeting. In collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions. Ensures collection of required essential documents from the sites prior to study initiation and maintains of currency of site level documentation throughout the study. May assist the project manager with quality reviews and or audits of the Trial Master File (TMF) to ensure inspection readiness. May support clinical monitoring activities, such as CRA training, development of annotated site visit reports and monitoring tools, perform visit report review, site letters, and identification of quality issues and trends related to site performance and clinical monitoring activities. May serve as a point of contact for CRAs and Lead CRAs for assigned projects. May track site qualification, initiation, routine and close-out visits, project-specific training, monitoring visit reports and follow-up letters, compliance with monitoring plan, escalation of site-related issues. Maintains the project specific training matrix and confirms project team members are fully training per the study matrix prior to team members performing study tasks Supports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.). In collaboration with the Data Management group, may ensure that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock. Support development of study-specific trackers and sites and Sponsors dashboards in Smartsheet. May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department The Project Manager I, EPTR, may also assume the following responsibilities: With adequately documented training, perform limited clinical monitoring activities such as, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations. Brand name: Indero Our company: The work environment At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) Ongoing learning and development Work location The successful candidate for this position is given the option to work from home anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives). Occasional visits to our Montreal headquarters may be required or encouraged. About Innovaderm Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North Americaand Europe. Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm 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: Le gestionnaire de projet, EPTR assure la bonne initiation, planification, excution, suivi, contrle et clture des projets de recherche clinique en phase prcoce qui lui sont confis. De plus, le gestionnaire de projet, EPTR est responsable de la gestion oprationnelle et de la supervision des sites investigateurs cliniques ainsi que des livrables de monitoring clinique des essais. Le gestionnaire de projet , EPTR doit veiller au respect du budget de ltude, du primtre du projet et des chanciers, conformment aux procdures oprationnelles standard (SOPs), aux bonnes pratiques cliniques, ainsi quaux exigences rglementaires et spcifiques chaque tude. Ces activits sont ralises sous la supervision troite dun Senior Project Manager / Program Director et/ou dun Director, EPTR. Ce poste sera parfait pour vous si: On peut compter sur vous pour livrer des rsultats dans un cadre de gestion de projet disciplin et structur. Vous cherchez passer la prochaine tape pour ventuellement devenir gestionnaire de projet. Vous avez plusieurs connaissances sur le droulement dune tude clinique et vous souhaiter continuer dapprendre. Travailler dans une organisation qui est alimente par la science et linnovation et apporter une contribution significative est important pour vous. RESPONSABILITS Plus spcifiquement, le Gestionnaire de projet associ, EPTR : Peut agir comme point de contact principal pour le sponsor, les sites, les CRAs, les fournisseurs et les quipes internes tout au long de ltude. Selon lenvergure du projet, peut en assurer la gestion. Coordonne les tches et les chanciers entre les diffrents dpartements impliqus dans le projet. Supervise les project coordinators, les membres de lquipe SSU ainsi que les ressources RDA et RAC afin dassurer une priorisation adquate des activits dactivation des sites. Collabore avec la gestion des fournisseurs afin dassurer lalignement des livraisons et services avec les chanciers dactivation des sites. Escalade au gestionnaire de projet lorsque les chanciers dactivation des sites sont risque ou ne peuvent tre respects. Contribue la gestion des besoins et des attentes du sponsor ainsi que des parties prenantes internes et externes. Contribue sassurer que tous les membres de lquipe sont adquatement forms sur le projet. Peut planifier les activits et les ressources ncessaires au projet (ressources internes et externes, quipements, etc.). Assure la qualit du travail et des livrables assigns. Contribue la communication des mises jour du projet aux parties prenantes internes et externes. Sassure que les …