Sso Study Start-Up Manager

OverviewThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country.
Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team.
In satellite countries acts as primary back-up and deputy of the country manager.ResponsibilitiesSupports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head PortfolioCollaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitmentsAccountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projectsEnsures close collaboration with local IRBs/IECs and Health Authorities, as applicableEnsures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as requiredPrepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)Coordinates timely response to deficiency letters in close collaboration with local and global stakeholdersCoordinates reportable events and notifications to IRB/IEC and Health Authorities as applicableAccountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readinessEnsures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplements innovative and efficient processes which are in line with Novartis strategySupports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study teamLeads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assignedIn satellite countries oversees local vendor selection and performance as needed.
Serves as main contact for quality/compliance issues in SSU phase, escalating as necessaryEnsures sites are prepared for "Green Light" and ensures all documentation is in place for initial and subsequent drug release.
Responsible for review and sign off of the site "Green Light"Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulationsLeads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as requiredLeads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU LeadIdeal BackgroundA degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferableFluent in both written and spoken EnglishMinimum 5 years' experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trialsCapable of leading in a matrix environment, without direct reportsUnderstanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoringSkills and KnowledgeStrong project management capabilities with demonstrated ability to problem solve and mediate complex issuesThorough 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 and Novartis standardsStrong interpersonal, negotiation and conflict resolution skillsCommunicates effectively in a local/global matrixed environmentSeniority levelMid-Senior levelEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical Manufacturing
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