Clinical Operations Lead

pIn 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. /pullipension /liliprivate medical insurance /liliremote work options /liliLead program strategy and ensure study alignment within the program /liliContribute to Clinical Development Plan feasibility, timelines, geographic strategy, and budget /liliMaintain integrated timelines and milestones including go/no-go decisions /liliServe as primary Clinical Operations interface for cross-functional teams /liliOversee end-to-end Clinical Operations activities /liliSupport CPMs on operational decisions and compliance (ICH-GCP, SOPs) /liliContribute to study design and feasibility assessments (CPAC) /liliEnsure consistency across studies within the program /liliDefine and oversee vendor/CRO strategies /liliSupport RFPs, evaluations, and Bid Defense Meetings /liliManage escalations and vendor governance /liliAccountable for program-level budget with planning, forecasting, and variance analysis /liliParticipate in governance bodies and present updates/risks /liliProvide functional supervision and escalation support to CPMs /liliCoach and develop CPMs (IDPs, objectives) /liliDrive risk mitigation, CAPAs, and inspection readiness /liliSupport regulatory documentation (eCTD, CSR/CIR) and registry submissions /liliSupport SOPs and continuous improvement initiatives /liliEnsure compliance with required training /liliAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline /liliSignificant experience in Clinical Operations in pharma/biotech or CRO /liliProven experience managing global clinical development programs across Early Phase, Late Phase and RWE /liliStrong understanding of CDPs and clinical development processes /liliExperience coordinating cross-functional teams and acting as key interface between Clinical Operations and other functions /liliSolid knowledge of ICH-GCP guidelines and regulatory requirements /liliExperience in CRO selection, oversight, and vendor management /liliStrong project/program management skills with timelines, milestones, risk management, and budget oversight /liliExperience managing complex integrated project plans and development timelines /liliProven ability to provide strategic and operational guidance in protocol development and study planning /liliExperience preparing clinical documentation for regulatory submissions (eCTD components) /liliPast experience with functional leadership or matrix management of CPMs /liliStrong stakeholder management and presentation skills /liliExcellent communication, analytical, and problem-solving abilities /liliAbility to work in a global, matrixed, multidisciplinary organization /liliFluency in English (written and spoken) /lilistrong communication /liliinfluencing and presentation skills /lilileadership and mentoring /liliICH-GCP /liliCDP planning /li /ulpClinical Operations Lead • ascoli piceno, marche, it /p #J-18808-Ljbffr