Clinical Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7r90y7

pstrongClinical Project Manager /strong /ppstrongWe are looking for a Clinical Project Manager (CPM) /strong to join our Clinical Operations team. /ppbr / /ppstrongRequirements /strong: At least 4 years of experience as a Project Manager /ppstrongWork Location: /strong Rome, Italy /ppbr / /ppstrongKey Responsibilities /strong /pulliLead, coordinate, and oversee interventional and non-interventional clinical studies involving medicinal products, medical devices, and medical nutrition. /liliManage cross-functional project teams, including Clinical Project Specialists (CPS), Clinical Trial Assistants (CTA), Clinical Research Associates (CRA), Data Managers, Medical Advisors, Biostatisticians, and external vendors. /liliEnsure that clinical projects are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), applicable regulations, and company Standard Operating Procedures (SOPs). /liliPrepare and oversee study documentation, including protocols, Investigator's Brochures (IB), IMPDs, and regulatory submission packages. /liliCoordinate regulatory submissions and communications with Ethics Committees and Competent Authorities. /liliMonitor project progress, identify and manage risks, and provide regular updates to sponsors and internal stakeholders. /liliOversee Trial Master File (TMF) management and ensure appropriate documentation throughout the study lifecycle. /liliManage project budgets, contracts with clinical sites and external vendors, and financial performance. /liliSupport quality assurance activities, including CAPA implementation, KPI monitoring,



and audit readiness. /liliAct as the primary point of contact for sponsors and project teams throughout the duration of assigned studies. /li /ulpstrongRequirements /strong /pulliBachelor's or Master's degree in Life Sciences or a related scientific discipline. /liliAt least 4 years of experience as a Project Manager in the clinical research field. /liliKnowledge of Good Clinical Practice (GCP) and Project Management methodologies. /liliExperience managing project budgets and cross-functional teams. /liliStrong leadership, organizational, communication, and negotiation skills. /liliAbility to manage multiple priorities while maintaining a strategic overview. /liliGood written and verbal communication skills in English. /li /ulpstrongPreferred Qualifications /strong /pulliPrevious experience managing interventional and/or non-interventional clinical studies. /liliExperience with regulatory submissions to Ethics Committees and Competent Authorities. /liliKnowledge of Trial Master File (TMF) management and applicable clinical research regulations. /liliExperience working in a Contract Research Organization (CRO) or pharmaceutical environment. /li /ulpstrongWhat We Offer /strong /pulliDynamic and international work environment. /liliOpportunity to lead complex and innovative clinical research projects. /liliProfessional growth and career development. /liliTraining and continuous learning opportunities. /liliCollaborative and multidisciplinary team. /liliWorkplace based in Rome, Italy. /li /ulpbr / /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7r90y7