08 set - Lazio
CROlife
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
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