The Company

Multinational Pharmaceutical Company

The Role

Clinical Project Manager

• collaborates for the development of clinical operational strategy and shapes the clinical development plan;
• drives the development of program level documents and plans and effectively leads a global team of individuals assigned to the program;
• accountable for the selection and management of external service providers
• ensures that study design, study plan and documents are aligned with the development strategy;
• collaborates in preparation of clinical development plan;
• manages of overall project status/timelines/budget;
• selects CRO/vendor; confirming services and timelines, representing the scope of work for the final agreement, and reviewing of costs including milestones of payment;
• primary escalation contact for any issues, along a study belonging the relevant project and definition of action plan for resolution;
• clinical operations representative at the Project Team;
• main point of contact for Economic Affair, Legal and
• Regulatory department for any project related activities;
• prepares and measures the performance of any project related activities managed in house or outsourced to vendors;
• coordinates of the clinical operational team assigned to the project/study in order to ensure that studies are conducted and documented properly according to the applicable regulations and in compliance with timelines and budged as planned;
• oversight of conduction, documentation and archiving of clinical trials according to study protocol, applicable regulations and guidelines
• coordinates/prepares clinical documents/sections as needed for clinical trial application and/or regulatory filings (clinical study protocol/IND/pediatric investigational plan/scientic advice);
• coordinates/prepares and quality controls of clinical part of regulatory dossiers for marketing authorization and any follow up until approval, as required;
• contributes to the preparation of clinical study report and publications

Personal Attributes

• Master degree or higher in scientific fields (Biology, Biotechnology, CTF, Pharmacy);
• A PMP / Prince certification will be considered a plus;
• 7 – 10 years of experience in Clinical field;
• Fluent english

Location: Firenze