When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.All Location US and CanadaThe Global Study Manager II (GSM II) provides operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred Contract Research Organization (pCRO), and vendor deliverables for all study management deliverables in a study.Key AccountabilitiesStudy Management OversightLeads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors, study start up through database release and inspection readiness to ensure timely delivery of quality study data. May also provide input to and support compilation of sections to clinical study reports (CSRs) as neededProvides quality oversight and coordination of regional and country operations and the pCRO for the tasks both owned by and delegated to Study Operational Managers (SOMs), if assigned to study, related to study executionProvides leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start up, monitoring, and other study level plans and delivery to the agreed plans by partnering with cross functional colleaguesServes as a critical member of the core team and represents the operational sub-team including applicable vendors and pCRO on matters of study executionDrives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategyProvides supervision and/or mentorship to SOMs and possibly other GSMsEnsures development of study level plans, including the study monitoring and study training plansDevelops, reviews, or approves the study startup, study monitoring, protocol recruitment, and training plans and other documents, guidelines, and plans. May delegate development of plans or components of plans to SOMs (if assigned) or to Clinical Study Team Assistants (CSTAs) as appropriateApproves and oversees drug supply management, manages flow of drug supply to the sites, and sets up interactive randomization systems with supply chain leadEnsures overall vendor oversight for vendors managed by SOMs (if assigned), action escalations related to vendor issues and escalates further as necessaryReviews consolidated pre-trial assessment (PTA) reports and feasibility outputs in partnership with appropriate cross functional colleaguesEnsures applicable system closure at study completionMay support study level submission readinessMay participate in vendor user accountability testing (UAT) and system setup requirements review and approval [e.G., Interactive Response Technology (IRT),



central lab]Study Management OperationsAccountable for study management and oversight of all study management functionsForms, oversees, and leads the operational sub team and requests resources as neededEnsures the development of realistic detailed study startup and/or study management strategies and monitoring plans, including sourcing strategy, input into requests for proposals, and for the selection of vendorsEnsures country level feasibility is completed in collaboration with cross functional departmental colleagues, organizations, and pCRO, reviewing PTA report outputs, approving sites, and assessing site activation plansEnsures Trial Master File (TMF) setup for study management and country and site level documentsProvides input into the risk planning process for the studyCoordinates development of study and protocol training and global investigator meetings (IMs)Ensures that local IMs are coordinated by the SOM, if assigned to studyDevelops and provides key inputs to clinical trial budget (e.G., per subject costs)Ensures that SOMs are inputting into the budget for local/country level tasks (if assigned), and reviews cost variance, invoices, and purchase orders (POs) in a timely manner to ensure that spend is appropriate and on track with the forecastMonitors the budget and contracts for assigned vendors [e.G., central labs, electronic patient reported outcomes (ePRO), radiology, pCRO]Accountable for the delivery of the study against approved plansWorks directly with cross-functional and department lines and pCRO to resolve or triage site level issuesLeads inspection readiness activities related to study management and site readinessSupports development and delivery of decentralized capabilities at investigator sitesEnsures timely study closure and release of internal and external resources as appropriate if assigned to study post database lockMonitors vendor contracts for out of scope activities and budget spend and invoices for assigned vendors (e.G., central labs, ePRO, radiology)Reviews study level metrics and analytics and ensures appropriate actions are taken to mitigate risks and resolve issuesWorks independently and demonstrates resourcefulnessMay, on occasion, take on the role and responsibilities of a SOMStudy Team InterfaceLeads and oversees all elements of study startup and monitoring functions to ensure delivery and compliance with all applicable SOPs and quality standards, interfacing directly with CRO feasibility and study startup, monitoring and management,



and site contracting groupsWorks proactively with data management functions and department colleagues to ensure alignment on data flow and timely deliveryRegularly reviews data reports and dashboards to identify risks and drive appropriate actionsShares and escalates plan deviations to CSTL and study team and drives and oversees mitigationsReview vendor expenses and workorders as per study budget for assigned vendors (e.G., central labs, ePRO, radiology, pCRO)Provides ongoing assessment of subject enrollment and discontinuations to inform accurate forecasting for financial planningProvides operational input into protocol designLeads protocol deviation trend review, partnering with the clinical teamMay lead and facilitate the routine study management vendor callsSubject Matter ExpertiseServes as technical expert for study management systems and processesChampions the implementation and use of harmonized, consistent processes, and excellence in study management deliverables related to cost and effective, timely, and high quality clinical trial data according to agreed global goalsProvides technical oversight of the operational sub team to include but is not limited to standards, continuous improvement, issue escalation and resolution, inspection readiness and quality assurance, performance feedback, review of metricsPartners with the operational sub team and pCRO to proactively identify and resolve study operations staff performance issuesMay serve as a resource to the study team in addition to the SOM(s), if assigned, to facilitate project specific audits and inspectionsSkillsRequires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a sub-business unit/sub-operating unit meets its goalsCreates an environment where innovation is standard, taking appropriate risks to advance innovative processesDevelops ideas and leads complex projects across sub-business unit/sub-operating unitDevelops creative solutions to complex problems impacting a sub-business unit/sub-operating unitExercises own judgment and is a resource for othersActs independently on self-initiated projectsExperienceExperience in clinical research and/or study managementStudy management/leadership experienceExperience with oversight of CROs and vendorsExperience in managing per subject costs, vendor and ancillary and monitoring costs projections and spendFluency in written and spoken English requiredAbility to work outside of core business hours, as required, to support global trials or initiativesAbility to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetingsKnowledge and ExperienceExceptional knowledge of study management processes and deliverablesGood knowledge in understanding the responsibilities beyond their function to ensure goals are met for the studyMaintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverablesWorking knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operationsEducationBachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience requiredMaster's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience requiredA scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology#LI-LG4 #J-18808-Ljbffr

📌 Global Study Manager Ii (Quebec City)
🏢 Parexel
📍 Quebec City