Milena Peraboni

Responsible for planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations.

• Responsible for 10+ trials across 4 different programs, contributing to success of key compounds both in oncology and in neuroscience, supporting achieving successfully multiple DBLocks and enhancing start-up activities, and managing multiple stakeholders, both internal and external, at different levels in complex matrix environment.
• Responsibilities include establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and final reports, supporting new and ongoing clinical research and clinical trials, monitoring adherence to protocols and determine study completion, manages clinical and regulatory files and collaborating with Country medical/clinical colleagues, global clinical teams.
• Permanent member of Monitoring Plan Review Team
• SME for eSerious Adverse Events
• Key skills: strong analytical skills, strategic planning and thinking, managing stakeholders at all levels within and outside company, working in complex multicultural matrix, quality oriented

• Accountable for oversight and coordination of global monitoring aspects from trial start-up to close-out visits, in collaboration with GCT/ICT/CTT, regions and CPOs, in compliance with Novartis processes, GCP, ICH and regulatory requirements.
• Responsible for 10+ trials across 3 compounds in oncology, achieved successfully all deliverables despite pandemic, contributing to programs success
• Responsibilities include strategic and operational planning, audit organization and inspection preparation activities.
• Permanent member of Monitoring Plan Review Team
• SME for eSerious Adverse Events
• Key skills: analytical skills, strategic planning and execution, quality oriented, stakeholders management

• Accountable for oversight and coordination of global monitoring aspects from trial start-up to close-out visits, in collaboration with GCT/ICT/CTT, regions and CPOs, in compliance with Novartis processes, GCP, ICH and regulatory requirements. Responsibilities include strategic and operational planning, audit organization and inspection preparation activities
• Successfully performed in 10+ trials across 2 compounds, in oncology, supporting registration trials, 20+DBlocks and HAs inspections, increasing enrollment and enhancing start up acitvities, shortening trial execution timelines.
• Permanent member of Monitoring Plan Review Team.
• SME for eSAE
• Key skills: analytical skills, strategic planning, stakeholders management, quality oriented

• Accountable for supporting Global BU by overseeing initiation, monitoring and closing of clinical studies.
• Responsible for representing GMO in CTT and ICT settings and central point of communication between CTT and CRAs.
• Contributed to development of CMM role, improved trial execution timelines, managed 8 trials in oncology, including key submissions
• Key skills: analytical skills, project management

• Responsible for supporting CTT in monitoring activities.
• Contributed to success of 2 key compounds and to establish cooperation frame with external stakeholder
• Hold and customized trainings on data collection, quality and study procedures to study monitoring teams.
• Key skills: project management

• Identify potential areas of compliance vulnerability and risk to develop and implement corrective action plans.
• Provide guidance, advice and training to improve business' understanding of related laws and regulatory requirements.
• Set up and hold 20+ GCP training events in clinical sites
• Key skills: analytical skills, coaching, quality oriented

• Responsible for monitoring activities for international phase II and III trials mainly in Oncology, both in solid tumors and hematology, occasionally in other therapeutic areas or phase IV trials.
• Acting as CRA Coordinator, Local Lead CRA and Global Lead CRA
• Mentor for junior CRAs.
• Key skills: project management skills, mentoring skills, education delivery skills

• Monitoring activities for international phase II and III trials in Oncology

• Freelance Data Manager for international phase II-IV studies at Ciba-Geigy, Italy

• Responsible to support in phase II-IV studies for internationally relevant companies
• Main tasks included

- Case Report Forms design

- Database design and implementation

- Listings/reporting design and implementation

- Implementation of automatic procedures for quality control

- Data entry and data cleaning