Clinical Study Manager

Smith Hanley is currently seeking a Clinical Study Manager for the Delaware area.Major ResponsibilitiesCoordinate operational aspects of study and lead and participate in activities that ensure quality, consistency, and integration of study data and progress SD deliverables to time cost and quality from Study Delivery Concept through database lock and study close-out activitiesImplement globally agreed Study Delivery and Clinical Development strategies including process and technology related to Study DeliveryEstablish and maintain key interactions with major customers (internal/external) and interface with clinical departments (e.g.. CIS) to ensure quality of SD deliverablesLead and/or participate in preparation and delivery of Study documents for example CRF, DMP, SDV plan, country specific study Management agreement for deliverables, country specific CSA, confidentiality agreements and clinical trial applicationsIdentify opportunities for, and lead or participate in the set up, and maintenance of e-clinical components of the study (e.g.. Secure document transfer, WBDC, ePRO, Study Webs, etc.)Ensure timely entry and/or update appropriate information into IMPACT and other SD communication toolsContribute to the planning and conduct of Investigator/monitors meetingsManage/Coordinate the supply and reconciliation of Study Materials and Investigational productDrive the quality, consistency, and ensure integration of study efficacy and safety data through to Clean File; Lead and conduct activities that ensure data capture, data validation (including query generation/resolution) and QC, and integration of coding activities that drive the quality, consistency, and integration of study data through to Clean File; Establish and maintain continuous data inflow to ensure complete and accurate study dataContribute to activities (e.g.. Defining and testing data checks, system User Acceptance Testing) that progress availability of tools and programs that facilitate data capture and validation activitiesContribute to development and maintenance of project module package library and module package components at study levelLead, coordinate, and/or perform SAE reconciliation activitiesManage external service provider (Third Party Vendor or CRO)Monitor study sites as applicableMonitor Study Conduct and progress, proactively identifying to and resolving with the SD Leader, issues which may impact study tracking, quality, timelines or budgetFacilitate strong MC and external partnerships and work with Marketing Companies, CROs, CPUs/Academic clinics to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure SD deliverables to time and qualityHelp in the development and implementation of plans associated with audits and regulatory inspections, providing link between SDL and CQASupport activities associated with audits and regulatory inspectionsProvide input into non-project work, training activities, and development of procedures as neededDemonstrate willingness to take on any level project activity consistent with current or past experience in support of study deliveryExperience/Min Requirements: 3 years experience. Protocol writing a must, Phase I, Blend of Clin Ops and DM desiredUniversity degree in biological science, health related field, licensed registered nurse or equivalent experienceRelevant industry or health related experienceProven organizational and analytical skillsUnderstanding of the clinical study and drug development process, GCP/ICH guidelines in relation to Study delivery operational activitiesDemonstrated ability to work independently, as well as in a team environmentAbility to prioritize
REQUIREMENTS
Pharm Group