Sr. Clinical Study Lead (Warren, NJ) Hybrid

KPS Life is looking for a Senior Clinical Study Lead (Sr. CSL) to be dedicated to one of our sponsor clients and working on-site in their office in Warren, NJ 3 days per week. This role is ideal for an experienced clinical operations professional who wants to lead the global execution of large, complex trials from protocol development through close-out. If you have a strong background in global study management within the pharmaceutical industry and enjoy driving cross-functional delivery, we’d love to connect.Senior Clinical Study Lead (Sr. CSL)The Senior Clinical Study Lead (CSL) is accountable for the support of global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the support of study timelines, study budget, and ensuring study conduct is in accordance with Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.Key ResponsibilitiesLeads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned studyProvides operational input into protocol developmentOversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.Supports compliance with the clinical trial registry requirementsIdentifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendorsProvides input into baseline budget development and managementProvides input into baseline timeline development and managementLeads risk assessment and identifies risk mitigation strategies at the study levelLeads the feasibility assessment to select relevant regions and countries for the studyOversees/conducts site evaluation and selectionLeads investigator meeting preparation and executionMonitors progress for site activation and monitoring visits and acts on any deviations from planLeads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from planMonitors data entry and query resolution and acts on any deviations from agreed metricsEnsures accurate budget management and scope changes for internal and external studiesOversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliationEscalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issuesOversees the execution of the clinical study against planned timelines, deliverables and budgetOversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sitesOversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of workSupports clinical project audit and inspection readiness through the study lifecycleSupports internal audit and external inspection activities and contributes to CAPAs as requiredManages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountabilityContributes to clinical study report writing and reviewFacilitates and contributes to study level lessons learnedAssigns tasks to Clinical Study Management staff and supports their deliverablesMay require 25% travelRequirementsBachelor's degree (or equivalent) and minimum of 8 years relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.Demonstrated interpersonal & leadership skillsAbility to understand and implement the strategic direction and guidance for respective clinical studiesA data driven approach to planning, executing, and problem solvingEffective communication skills via verbal, written and presentation abilitiesProactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritizationAbility to influence and negotiateBudget management experienceAn awareness of relevant industry trendsAbility to build productive teams and collaborationsDemonstrated vendor management experienceTechnical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRSExperience in global clinical trial operations including experience developing protocols and key study documentsKnowledge of ICH/GCP and regulatory guidelines/directivesEffective project management skills, cross-functional team leadership and organizational skills