• Responsible for management/oversight of study 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 CRO 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. • Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation • Leader of the Local Study Team (core members: (Lead) Site Care Partners, Clinical Trial Associate, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders 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. • Provides protocol level guidance and support to responsible Local Study Team members as applicable. • Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees • Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered • 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 • Follows up on region/country level issue status to ensure resolution. Identifies country level trends to improve deliverables processes as needed • Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies • Ensures audit/Inspection readiness during start-up and conduct • Manages applicable Quality Events with pCRO and local team as applicable and required • Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets • Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable • Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable • Responsible for PTA and SIV report review for reports completed by the Site Care Partner • Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions • Ensures pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Associates and other roles as required • Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.) • Support Identification, contract development and management of local vendors or facilities as per protocol • Investigator Meeting support and management including doing presentations as appropriate • Management of local Investigator Meetings including doing presentations as appropriate

• Own process and cost analysis, operations planning and orchestration for complex technical construction and deployment projects • Lead pre-construction planning activities, including scope definition, constructability reviews, sequencing strategies, and feasibility assessments • Develop and maintain cost estimates, budgets, and financial models, including scenario and sensitivity analyses to support executive decisions • Build and refine process analytics related to construction workflows, timelines, cost drivers, and risk exposure • Partner with engineering, operations, procurement, and finance teams to ensure alignment between technical requirements and cost realities • Create structure where none exists—establishing frameworks, templates, and repeatable processes appropriate for a rapidly scaling environment • Identify risks and opportunities early and clearly communicate tradeoffs to senior leadership • Support leadership decision-making by delivering concise, data-backed insights under compressed timelines • Adapt plans quickly in response to changing project scope, priorities, or executive direction • Coordinate with global stakeholders, including supporting collaboration across U.S. and Japan time zones

• Maintain ultimate responsibility project scope, schedule, budget, and success criteria • Manage RAID (Risks, Actions, Issues, Decisions), change management, integrations, and go-live readiness • Drive client confidence and adoption through structured execution • Prepare and deliver weekly executive-level status reports to customers and internal leadership • Support business process mapping across Procure-to-Pay, Maintenance & Work Management, Capital Projects, and Accounts Payable • Translate business needs into clear, actionable implementation requirements • Act as the primary delivery interface between customers and internal technical teams • Escalate design tradeoffs, feasibility constraints, and roadmap impacts • Ensure delivery remains within supported product capabilities • Maintain proactive communication with Sales and Account Executives • Propose implementation approaches aligned with product standards and architectural guardrails with a hands-on process for application configuration, testing, and integration • Coordinate integration sequencing across ERP systems and external applications • Maintain ownership of Azure DevOps project workstreams and technical ticket visibility • Identify technical risks related to integration design, data migration, performance, scalability, and unsupported configurations • Drive mitigation plans in partnership with Solution Architects and Engineering • Enforce scope boundaries and protect project margins • Prepare, price, and manage formal change orders • Ensure implementations follow established delivery methodology and quality standards • Contribute to continuous improvement of standards, templates, and delivery methodology • Share lessons learned to improve scalability and consistency

Role Description Alma Laboris ha avviato il processo di candidatura ai percorsi di Alta Formazione nel settore farmaceutico, offrendo agevolazioni e un servizio di Placement dedicato a supportare concretamente lo sviluppo della tua carriera. L’obiettivo è formare e specializzare professionisti altamente qualificati, pronti a essere proposti alle aziende partner della rete. Il Master in Management e Marketing dell’Industria Farmaceutica è progettato per favorire la crescita professionale attraverso contenuti specialistici e immediatamente spendibili, che includono: - Direzione Medica - Affari Regolatori - Monitoraggio dei Processi e Controllo Qualità della Produzione - Farmacovigilanza - Gestione delle Risorse Umane - Market Access e Marketing Farmaceutico - Business Development e Sales Management - Project Management Durante il percorso avrai accesso a strumenti concreti per entrare in contatto con le aziende partner: - Assistenza individuale con un tutor esperto del mercato - Accesso al portale esclusivo “Network”, per candidarti agli annunci pubblicati dalle aziende partner - Promozione del profilo alle aziende interessate a fissare colloqui per diverse posizioni aperte Il servizio di Placement registra un tasso di successo del 90%, assicurando un collegamento diretto tra formazione e opportunità professionali. Qualifications - Professionisti già operanti in azienda: Product Specialist, KAM, Regulatory Specialist, Public Affair Manager, Product Manager, Market Research Specialist, Responsabili Marketing, Direzione Commerciale, QA, Informatori Scientifici, ecc. - Titolari e collaboratori di farmacia che vogliono acquisire una visione aggiornata della gestione moderna dell’industria farmaceutica - Consulenti e professionisti specializzati interessati a comprendere meglio gli aspetti economici e organizzativi delle aziende con cui interagiscono - Laureati in discipline affini: Farmacia, Chimica, Scienze Biologiche, Medicina, Veterinaria, Biotecnologia, Economia e Marketing - Giovani professionisti provenienti da altre lauree interessati ad acquisire competenze concrete e immediatamente applicabili nel settore Notes Con la candidatura riceverai informazioni sulle attività formative e sulle opportunità di sviluppo di carriera.