Senior Project Manager Early Phases | Innovaderm Research Inc. |Canada

We are looking for a Senior Project Manager, early phases (based ineither Poland or Canada).

We are looking for a Senior Project Manager, early phases (based ineither Poland or Canada).Senior Projects Managers are crucial to the success of Clinical Trialsmanaged by Innovaderm. They are the main point of contact internally aswell as externally, ensuring all activities and deliverables are completedon time, on budget, and as expected.Great project managers go further than creating project plans andfollowing up on tasks. They show leadership to help project teams focus onobjectives and deliver results.This role will be perfect for you if:You are a hands-on project manager who enjoys working on multi-siteearly phase projects including Phase I, Phase IIA / proof of concept aswell as Investigator-Initiated studies.You enjoy helping look for ways to improve and simplify processes tobetter respond the needs of Early phase projects in a regulatedenvironment.You wish to work for a mid-sized CRO that works on significantmultisite trials, including Global Phase III projects.You are looking to position themselves in an environment where you cangrow your career alongside of a growing company.IMPACT AND RESPONSIBILITIES Client interactionsServe as primary contact for the SponsorProvide efficient and timely updates on trial progressLead client calls effectivelyProject planningOversee and actively participates in the preparation of projectdeliverables such as; study plans, protocol, informed consent form,electronic case report form (eCRF), tables/listings/figures (TLFs),clinical study report.Participate in the planning and conduct of the Investigator’sMeeting.Ensure that each site has the necessary material to adequately performthe study (e.g., investigational product, study supplies, specialequipment, safety lab kits, etc.).Quality and risk managementEnsure assigned studies are “audit ready” at all times.Monitor the quality of study deliverables, (including vendor and SubCROdeliverables) and address issues as they arise.Manage risk and control measures to assure project quality.Analyze discrepancies between planned and actual results.Review and approve responses to quality assurance audits.Project budget and timelinesControl the project budget, with particular attention to internal hoursallocated to all activities.Identify out of scope activities for change orders.Proactively manage operational aspects of the clinical trial includingtrial timelines, budget, resources and vendors. Coordinate tasks anddeliverables from all functional departments involved in the project.Communicate effectively with study team members, functionaldepartments, and senior management.Manage and report on recruitment status and highlight initiativesneeded to meet recruitment timelines.Project team leadershipLead the core project team which may include: Associate ProjectManagers, Project Coordinators, Project Assistants.Ensure all team members have adequate training on the project.Work closely with vendors and the following internal teams to ensureall tasks and deliverables are completed on time, according to plans andaccording to applicable standards: Site Selection, Regulatory Affairs, DataManagement, Clinical Monitoring, Biostatistics, Scientific Affairs. Department oversight supportSupport the Director of Early Phase and Translational Research for theoperational strategy (i.e. key operational success factors, gaps from bothvendors and internal factors, risk identification and mitigation, projecttimeline, target countries, number of sites, outsourcing vendor needs,etc.) in proposals sent to prospective clients for new businessopportunities.Support the Director of Early Phase and Translational Research indepartment oversight, including development and tracking of KPIs.REQUIREMENTSB.Sc. in a related field of study to clinical researchM.Sc. or Ph.D. an assetAt least 7 years industry experience;At least 5-7 years of clinical project management experience, includingmanagement of all projects phases from start up to closure, management ofall functional services, vendor management.Experience leading multi-centered, multinational phase III clinicaltrials including project budget financial tracking and forecastingExperience in one or more of the following considered an asset: studystart up, regulatory submission, resource management, supervisoryexperience, CRA, data management, medical writing, or vendormanagementExperience managing dermatology trialsExperience in SAD-MAD studies is an assetExperience in clinical site operations is an assetExcellent knowledge of GCP and ICH standards, local countryregulations;Excellent knowledge of Microsoft Office suite;Fluency in English with excellent oral and written skills,requiredBilingualism (English and French) is an assetAbility to work in a team environment and establish good relationshipswith colleagues and sponsors;Good problem-solving abilities;Strong ability to carry out different projects and work under pressurewhile meeting timelines; Show more Show lessTagged as: remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home