TMF Study Owner (Boston/Cambridge areas)

ATTENTION Boston and Cambridge, MAThe Professional Services team at Cencora Pharmalex are a diverse set of individuals with unique expertise and experience, offering Study Resources, Study Services and Consulting Services to customers. The services are designed to work independently as well as collaboratively, fitting the customer’s needs and budget.PurposeThe TMF Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients’ Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health, consistency, and compliance across clinical trials within the organization.This is a fully remote role with working hours expected to match the requirements of the customer’s business day. Travel is not an expectation of the role, however occasional travel may be required depending on customer requirements, for example in the case of an inspection or to complete paper TMF activities.Key ActivitiesDocument Management & QualityRemain familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices.TMF ManagementSupport the setup of the study-specific TMF structure, liaising with the Study Team to establish requirements.Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented.Monitor milestones and events to ensure TMF Completeness via eTMF functionality.Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team.Support study team through closeout and archive preparations.Ensure ongoing adherence to TMF SOPs and specifications.Create study-specific TMF Index (or equivalent).TMF Health & MetricsPerform and/or support QR and perform spot-checks for quality oversight.Provide TMF Health status updates and review metric reports outputs with the study team on a recurring basis, including verbal and/or written summaries.Help facilitate, track, and support periodic Study Team TMF Reviews.Maintain TMF Health oversight over study lifecycle.Provide guidance on how to improve and maintain TMF Health.Review metric report outputs with Study Teams on a recurring basis.Perform a deep-dive of report outputs; identify and share trends and risk areas with Study Teams.Provide guidance on how to improve and maintain metrics.Inspection ReadinessManage remediation and retrospective reconciliation projects.Manage inspection preparation.Support audits and inspections.Support implementation of CAPAs at study level.Identify and escalate risk and trends impacting Inspection Readiness.Customer RelationshipsFacilitate TMF-focussed communication and collaboration between Sponsor and CROs.Communicate to the Study Manager (or equivalent) on all aspects of the TMF.Build proactive relationships with study teams, providing continued SME support.Understand and utilise appropriate escalation pathways.Policies & ProceduresProvide feedback on processes relating to TMF Management.Training & MentoringAct as TMF SME, including related processes, to provide ongoing support to Study Team.Provide feedback to support development of internal and/or external TMF-related trainings.Conduct training for Study Team and/or colleagues, either 121 or in group setting.Minimum Required Skills & ExperienceTechnical Expertise - 5 years relevant industry experience in Clinical or TMF Operations oversight.Excellent knowledge of:Good Documentation Practices (GDP)Document recognitionGood knowledge of:Referencing/Applying applicable resourcesWorking knowledge of:Clinical trial lifecycleTMF Reference Model (or equivalent)eTMF systemsTMF Health & Metrics, including Quality Review processInternal communication/escalation pathwaysFamiliar with:TMF lifecycleOther clinical/document management systemsTMF stakeholdersEnd to end tasks, including TMF set-up process and Management PlansTMF trainingInspection ReadinessExternal communication/escalation pathwaysSoft Skill ExpertiseProficient in:Verbal and written communicationIndependent in:Internal collaborationInterpersonal interactionsOrganizationPrioritizationExperienced in:Coaching & mentoringPresenting informationDeveloping in:External collaboration and negotiation/conflict resolutionWorking under pressure and Information AnalysisWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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