The Company

Multinational Pharmaceutical Company

The Role

Clinical Study Manager

• preparation and performance of international clinical trials when managed in house or outsourced to vendors (e.g. CRO);
• assisting the Clinical Operations Projects Leader in the planning and execution of the development of the clinical operational strategy;
• coordination of study team activities to ensure successful completion of all clinical deliverables according to the study timelines and budget;
• oversight of conduction, documentation and archiving of clinical trials according to study protocol, applicable regulations and guidelines;
• detection and resolution of any issues, deficiencies, or delay along the study conduct, and definition of corrective and preventive actions;
• lead the study execution, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of the Company.
• drafts and collaborates to dene the study design, the study protocol and all study documents (e.g. protocol and amendments, informed consent form;
• designs study architecture and achieves the nal approval of participating countries and sites;
• collaborates to select of CRO/vendor, by review and alignment of services (quantity, quality, timelines and budget);
• plans and coordinates of all internal and/or outsourced activities required for the conduct of study and study deliverables (e.g. site agreement, clinical supplies, IXRS, pharmacokinetics, data management, etc);
• ensures complete and timely executed Clinical Trial Application to Competent Authorities (Regulatory Authorities and Ethics Committee);
• collects, documents and archives all needed internal and external approvals to ensure the compliance to ICH GCP, SOPs and regulations;
• oversees the performance of CROs, third party vendors, sites and CRAs to ensure compliance with
• study protocol and in accordance with scope of work (timelines and budget);
• detects and properly escalates issues, deficiencies, or delay along the study conduct, and defines the proper corrective and prevention actions to resolve them;
• maintains accurate and up-to-date study information;
• oversees the proper management of safety events observed during the study conduction
• provides study status as required for the periodic update of IMP documentation (e.g. IB, IMPD, IND, DSUR, etc), interaction with Pharmacovigilance Unit;
• prepares and manages of all meetings (e.g. investigator/CRA meeting, etc) required for the proper oversight and progression of the study;
• elaborates presentation of investigational medicine product and study characteristics;
• ensures the proper set up of the TMF/eTMF and of the final study documents reconciliation; oversees study documents archiving to ensure inspection readiness;
• contributes in the preparation of clinical study report and publications, and clinical sections of regulatory dossiers;
• ensures that all study team members and vendors involved in the study management are properly trained on study protocol and applicable procedures by ensuring the collection and archiving of all required training records.

Personal Attributes

• Master degree or higher in scientific fields (Biology, Biotechnology, CTF, Pharmacy);
• 5 years of experience in Clinical field;
• Fluent english

Location: Firenze