The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to 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.\nProject\nManager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline) This role will be perfect for you if: You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects\nYou are looking to position yourself in an environment where you can grow your career alongside the company IMPACT AND RESPONSIBILITIES Client interactions\nServe as primary contact for the Sponsor\nProvide efficient and timely updates on trial progress\nLead client calls effectively Project planning Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.\nParticipate in the planning and conduct of the Investigator’s Meeting.\nEnsure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).\nLead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.\nCollaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.\nPartner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met. Quality and risk management\nEnsure assigned studies are “audit ready” at all times.\nMonitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.\nManage risk and control measures to assure project quality.\nAnalyze discrepancies between planned and presente results.\nReview and approve responses to quality assurance audits. Project budget and timelines Control the project budget, with particular attention to internal hours allocated to all activities.\nIdentify out of scope activities for change orders.\nProactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.\nCommunicate effectively with study team members, functional departments, and senior management.\nManage and report on recruitment status and highlight initiatives needed to meet recruitment timelines. Project team leadership Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.\nEnsure all team members have adequate training on the project.\nWork closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs. Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study. Requirements\nEducation B.Sc. in a related field of study to clinical research Experience At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management\nExperience managing dermatology and/or rheumatology trials\nExperience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.\nExperience managing dermatology trials an asset Knowledge and skills\nExcellent knowledge of GCP and ICH standards, FDA and Canadian regulations\nExcellent knowledge of Microsoft Office suite\nExcellent oral and written skills in English, French is an asset Excellent communication skills\nAbility to work in a team environment and establish good relationships with colleagues and sponsors\nGood problem-solving abilities\nGood organizational skills\nStrong ability to carry out different projects and work under pressure while meeting timelines Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness.\nWe offer a stimulating work enviro