27 set - Ascoli Piceno
Chiesi
In this Clinical Operations Lead role, you will guide strategic and hands-on management of global clinical development programs across Early Phase, Late Phase and RWE studies. You will align cross-functional teams within the Clinical Development Plan and mentor Clinical Project Managers. You’ll oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance. This is a chance to shape programs at a financially responsible, highly collaborative biopharma group with a strong patient focus.Se desidera conoscere i requisiti per questo ruolo, continui a leggere per trovare tutte le informazioni pertinenti.pensionprivate medical insuranceremote work optionsLead program strategy and ensure study alignment within the programContribute to Clinical Development Plan feasibility, timelines, geographic strategy, and budgetMaintain integrated timelines and milestones including go/no-go decisionsServe as primary Clinical Operations interface for cross-functional teamsOversee end-to-end Clinical Operations activitiesSupport CPMs on operational decisions and compliance (ICH-GCP, SOPs)Contribute to study design and feasibility assessments (CPAC)Ensure consistency across studies within the programDefine and oversee vendor/CRO strategiesSupport RFPs, evaluations, and Bid Defense MeetingsManage escalations and vendor governanceAccountable for program-level budget with planning, forecasting, and variance analysisParticipate in governance bodies and present updates/risksProvide functional supervision and escalation support to CPMsCoach and develop CPMs (IDPs, objectives)Drive risk mitigation, CAPAs,
and inspection readinessSupport regulatory documentation (eCTD, CSR/CIR) and registry submissionsSupport SOPs and continuous improvement initiativesEnsure compliance with required trainingAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific disciplineSignificant experience in Clinical Operations in pharma/biotech or CROProven experience managing global clinical development programs across Early Phase, Late Phase and RWEStrong understanding of CDPs and clinical development processesExperience coordinating cross-functional teams and acting as key interface between Clinical Operations and other functionsSolid knowledge of ICH-GCP guidelines and regulatory requirementsExperience in CRO selection, oversight, and vendor managementStrong project/program management skills with timelines, milestones, risk management, and budget xysqume oversightExperience managing complex integrated project plans and development timelinesProven ability to provide strategic and operational guidance in protocol development and study planningExperience preparing clinical documentation for regulatory submissions (eCTD components)Past experience with functional leadership or matrix management of CPMsStrong stakeholder management and presentation skillsExcellent communication, analytical, and problem-solving abilitiesAbility to work in a global, matrixed, multidisciplinary organizationFluency in English (written and spoken)strong communicationinfluencing and presentation skillsleadership and mentoringICH-GCPCDP planningClinical Operations Lead
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