Country Study Operations Manager I - Italy will report into Lorenzo Majerini Director/Supervisor of Study Management JOB SUMMARY The Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention). The Study Operations Manager will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study. The Study Operations Manager may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
The Study Operations Manager has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The Study Operations Manager I may lead specific parts of the project or drive specific countries. They may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. They will ensure the operational delivery of responsible tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.
JOB RESPONSIBILITIES Operational Study Management Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close.May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable.Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements.Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning.Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans).Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.Ensures compliance to relevant Global and Local, internal and external requirements and regulations.Ensures timely communication bidirectionally between the global and local study team.Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams.Identifies country level trends to improve deliverables processes as needed.BASIC QUALIFICATIONS: Training and Education Relevant operational clinical trial experience.A scientific or technical degree is preferred along with knowledge of clinical trial methodology.BA/BS 5+ years of relevant experience.MBA/MS 3+ years of relevant experience.Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility.English is required.Prior Experience Demonstrated clinical research experience and/or study management/startup project manager experience.Demonstrated experience in managing country level operational activities and/or vendors.Experience in Study and Quality management and working in a matrix management environment.Skills and Technical Competencies Expertise in the use of study/site dashboard and reporting tools.Detail oriented & possesses technical expertise.Ability to manage moderately complex processes.Ability to operate in a matrix environment.Excellent communication skills, both written and verbal.
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