Part of the Clinical Sciences team, the Clinical Trial Management (CTM) group is responsible to manage and execute high quality standard and enriched phase I studies in healthy volunteers and phase II studies in patient populations conducted worldwide such as:

1. FIM, Dose escalation, Repeat dose, Drug-Drug interaction, Bioequivalence, Food effect, Imaging (PET, MRI ...), ADME, QTc.
2. Experimental and methodological studies either in healthy volunteers and patients, including PK/PD, challenge, proof of mechanism (POM), and Imaging.
3. Multicenter Phase II safety and efficacy patient studies, either in Italy or in an international setting.

Study management responsabilities span from study conception to reporting and cover:

Feasibility process: country/center/investigators evaluation and selection based on cost effectiveness, quality and timelines;
Site management: site validation, initiation, Investigator meeting, staff training, study file maintenance, monitoring and supervision of field monitors (CRAs); Recruitment strategy and risk management plans;
Vendors and third parties selection and management: including benchmarking and competitive bidding, contract development and performance metrics;
Financial awareness: Study budget set-up and maintenance, milestone and invoice tracking to ensure financial accuracy;
Regulatory Knowledge: Broaden knowledge of Ethics and Regulatory requirements and ICH Good Clinical Practices;
Scientific Writing: Scientific writing expertise as part of the study related activity, to develop the study clinical protocols, IB and associated study documents, to deliver the integrated clinical study reports and to produce clear and accurate written scientific communications;
Clinical Study Management: Strong clinical study management expertise in coordinating the activities and deliverables of internal and external partners by proactively identifying and resolving issues to achieve the successful completion of specific project goals in accordance.