Clinical Trial Manager

  The Clinical Trial Manager (CTM) is responsible for the day-to-day operational management and execution of assigned clinical trials from study planning through closeout. Working with appropriate oversight from Clinical Operations leadership, the CTM leads study execution, coordinates the cross-functional study team, and provides sponsor oversight of CROs and other external vendors to ensure study milestones, quality, budget, and operational objectives are achieved.The CTM is expected to independently manage study activities, identify and address operational risks and issues, drive routine study decisions, and appropriately escalate significant risks, issues, or decisions. The CTM applies sound judgment and initiative while ensuring trials are conducted in accordance with the protocol, applicable regulatory requirements, ICH-GCP, company procedures, and quality standards.This role can be hybrid to Norwood, Ma onsite 3 days a week or remote with monthly travel to Norwood, Ma or based in greater London area with some travel to US.RESPONSIBILITIESEnsure compliance with protocol and overall objectives across all investigator sitesPerform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelinesWork closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomesExecute study activities according to study protocol, regulatory guidelines and operational plansReview Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and proceduresKeep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standardsParticipate in study start-up, conduct and closeout activitiesAssist in preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWsCollect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)Assemble and distribute regulatory binders to clinical sitesDraft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)Lead study team meetings and ensure appropriate agendas, meeting documentation, action items, decision logs, study trackers, and follow-up are maintained; perform these activities directly as needed. Assist with preparation and distribution of investigator site contracts and budgetsMaintain the Trial Master File all clinical projectsLead the day-to-day operational execution of assigned clinical trials, with appropriate oversight from Clinical Operations leadership, using strong project management, leadership, judgment, and organizational skills.Develop comprehensive study timelines and metricsDevelop and manage study budget within financial goalsManagement of risk associated with KPI and issue escalationPrepare and present project briefings, as required; plan, execute, and lead or participate in study-specific meetingsCoordinates and participates in periodic data quality review and may contribute to interpretation of clinical trial resultsCoordinates with Data Management, Statistics, Medical and other functions for full life cycle management of clinical trial activitiesIdentify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendationsAssist in the selection and evaluation of study personnel (contract and internal)Provide or facilitate study-specific training to clinical research staff, and other contract personnelManage study-related vendors and serve as the primary point of contact for all contracted vendors (CROs, SMOs, Labs, Meeting Planner, etc)Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metricsParticipate in site and country selection. Review completed feasibility questionnaires to assist with site selection. Develop relationships with investigators and site staffPrepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site paymentsOversee clinical monitoring activities, ensuring compliance with (GCP) and applicable regulationsParticipate in site co-monitoring visits as appropriateSupport the design of clinical trial protocols along with the study team and consistent with the clinical development planIn collaboration with the Clinical Scientist, develop ongoing data review plan to ensure data trend detection and study objectives are metPrepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.Prepare and/or review study-related documents including the Site Performance Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and Risk Mitigation PlanProvide input and support documentation for adverse event safety monitoring while collaborating on FDA and regulatory authorities report submissionsCoordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distributionParticipate in planning of QA activities and coordinate resolution of audit findingsEnsure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issuesCoordinate and assist regulatory or ethics committee activities planningProvide oversight to maintain clinical trial master files and ensure appropriate compliance and completenessFor any study CAPA raised perform a root cause analysis, as well as drive all actions to completion, within the expected timeframeLead and consistently be present for the Cross-Functional Study Team as well as for internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)May represent Clinical Operations in other cross-functional activities or participate in functional initiatives in support of departmental objectives