The SSO Clinical Project Manager (CPM) is accountable fthe day-to-day planning, executing andreporting, (from first site initiation visit to including study site close-out), of assigned Global DrugDevelopment (GDD) studies in compliance with Novartis processes regulatory requirements.The CPM is the single point of contact study team lead, within the country/cluster/hub, ftheassigned studies. The CPM is responsible fassuring aligned communication with Trial Lead andother CTT members, locally with Clinical Research Associates (CRAs), CRA Managers other keyassociates on the execution progress of their studies. The CPM collaborates with the SSO CountryManager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager SSO Site Partnership Manager in the planning, execution, delivery of their assigned studies. Accountable fexecution reporting of assigned GDD studies in E2E product line Clinical Operations ProgramHead/Study Lead/ CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
Key responsibilities:
Study & Site Operations strategy
•Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans timeline commitments
•Participates in the recruitment sub-team supports the development of innovative solutions fsite patient participation to ensure the delivery of assigned studies on time
•Proactively identifies risk opportunities fthe assigned studies within the country/cluster/hub develops respective mitigation plans
Initiation conduct of trials
•When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, operational aspects of the study
•Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites Country/Cluster/Hub personnel
•Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, mitigation plans), to ensure all study operational aspects are on track
•Ensures recruitment targets are met reviews enrolment at the site level including responsibility fgetting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
•Oversees local study team activities to achieve study timelines quality execution, (proposing implementing corrective actions where appropriate), according to Novartis standards relevant regulations
•Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required is the single point of contact fthe conduct of assigned studies
•Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons discontinuation rates, review of patient profiles, proactively identifies data entry issues (on quality timing) to mitigate queries, proactively identifies query resolution issues
•Coordinates the study handover process with CRAs their managers to ensure proper documentation communication, when necessary
•Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs key study stakeholders
Delivery of quality data compliance to quality standards
•Conducts coordinates training, as needed, fCRAs to support site readiness to recruit study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee SOP requirements
•Conducts coordinates local investigatmeetings as needed ensures relevant documentation of training is archived in the Trial Master File
•Evaluates potential challenges/risks within the protocol operational aspects of the study
assessing impacts, develops risk management plans communicates/ escalates to global teams SSO Hub Head Portfolio, as appropriate
•Accountable fmonitoring quality issue resolution through timely review approval of study monitoring visit reports to ensure quality trial oversight appropriate issue escalation
•Promotes a compliance culture advocating the adherence to highest standards ethical integrity, ensuring human subject protection reliability of trial results at all times
•Escalation point fissues in monitoring visit reports (MVRs) fthe assigned studies. Responsible fevaluating trends identified in MVRs communicating/escalating to global teams, as appropriate. Communicates with CRAs their managers to ensure issue resolution in a timely manner
•Provides feedback about the quality of monitoring activities to CRA Managers, MSOM, SSO Country Managers, FSP/BiS line managers (as propriate) local QA (when required per Novartis SOPs)
•Supports inspection readiness submission preparation fmonitoring related activities assists coordinates with country Portfolio Execution Quality Assurance finternal auditsganization HA inspections, as required, ensures implementation of corrective actions within specified timelines
•Participates in multidisciplinary taskforces to support continuous improvement initiatives
Budget productivity
•Monitors the status of site budget contract negotiations as well as the collection review of essential documents throughout study conduct
•Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF preparation submission
•Processes invoiceable items fsite level clinical study activities to allow timely payments
Essential requirements:
•A degree in scientific health discipline required advanced degree with clinical trial experience and/project management, is preferable
•Fluent in both written spoken English
•Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/with monitoring clinical trials
•Capable of leading in a matrix environment, without direct reports working cross-border managing study in various countries
•Understanding of all aspects of clinical drug development with particular emphasis on monitoring study execution
•Strong project management capabilities with demonstrated ability to problem solve mediate complex issues
Desirable requirements:
•Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations Novartis standards
•Demonstrated negotiation conflict resolution skills both internal external (site relationships)
•Communicates effectively in a local/global matrixed environment
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职位要求：
Collaboration
Clinical Study Reports
Data Analysis
Regulatory Compliance
Clinical Research
Health Sciences
Budget Management
People Management
Clinical Trials
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