Senior Study Manager- Research Collaboration

2 months ago

Southeast Fairbanks, United States Parexel Full time

SSM- Research Collaboration- Center of Excellence

The Senior Study Manager (SSM) leads and manages the tactical execution of one or more clinical studies of moderate complexity from study startup through database release and inspection readiness to ensure timely delivery of quality study data

RC COE Focus:

Provide strategic advice and expertise on potential collaborations

Provide project management to increase efficiencies

Process streamlining and reduce timelines

Monitor KPIs and program needs

Provide Training and responding to queries

Improve Outcome reporting

Providing accurate and timely reports to monitor research collaborations progress

Study Management Oversight

Provides Operational Study Management for one or more studies of moderate complexity, generally with responsibility for all study management aspects of assigned studies.Accountable for the development of realistic detailed study start-up and monitoring plansAccountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and Contract Research Organizations (CROs), reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plansLeads study risk planning process in context of site and subjectCoordinates study/protocol training and Investigator MeetingsDevelops and provides key inputs to Clinical Trial Budget (e.g., per subject costs)Accountable for the delivery of the study against approved plansLeads inspection readiness activities related to study management and site readinessMay produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriateMay expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain (SC) Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)Approves the Study Start-up, Study Monitoring, and protocol Recruitment PlansProvides quality oversight to the CRO and of the CRO deliverables related to study executionMay provide input to and support compilation of sections to Clinical Study ReportsProvides leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plansDrives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategyMay be required to act as 'Lead' SSM and will coordinate activities of the other SSMs assignedApproves and oversees drug supply management - manages flow of drug supply to the sites and set-up Interactive Voice Randomization System (IVRS) with Supply Chain LeadReviews consolidated Pre-trial assessment reports, feasibility outputs, etc.May support study level submission readinessStudy Team InterfaceLeads and oversees all elements of study start-up and monitoring functions both internally and at the CROs to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and Quality StandardsServes as a core member of the Study Team and will represent the CRO on matters of study executionPartners with functional lines and directly with CRO line functions to resolve or triage site level issuesInterfaces directly with CRO to determine Feasibility/Study Start-up, Monitoring/Management, and Site Contracting GroupsWorks proactively with CRO and data management functions to ensure alignment on data flow and timely deliveryShares and escalates plan deviations to CSTL and study teamProvides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planningProvides operational input into protocol designSubject Matter ExpertiseServes as the 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-effective, timely, and high-quality clinical trial data according to agreed global goalsConducts the technical oversight of the CRO to include, but not limited to mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, and review of metricsPartners with CRO Managers to proactively identify and resolve study operations staff performance issuesMay serve as a resource to the study team to facilitate project-specific audits and inspectionsCompliance with Parexel StandardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills:Must be fluent in EnglishDetail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)Ability to interpret study level data and translate and identify risksAbility to proactively identify and mitigate risks around site level in study executionCountry level cultural awareness and strong interpersonal skillsKeen problem-solving skillsExcellent communication skills, both written and verbalKnowledge and Experience:Extensive global clinical trial/study management experienceWorking knowledge of Good Clinical Practices, monitoring, clinical and regulatory operationsDemonstrated study management/leadership experienceDemonstrated oversight of CROsDemonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spendUnderstands how to work with vendors to accomplish tasksUnderstands feasibility of protocol implementationEducation:For Bachelor's of Science degree or Nurse – minimum of 5 years relevant experienceFor Master's of Science degree or Doctor of Philosophy degree – minimum of 3 years relevant experience
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