Silvia Cirillo
Bologna
Summary
Respectful Clinical Operations Manager with extensive knowledge of health care administration and clinical philosophy. Talented at maintaining and developing effective relationships with staff, investigators and senior management. Excellent supervisory skills and performance working under pressure.
Multitasking, detail-oriented professional with exemplary skills in delegating tasks, issue resolution and leading by example. Offering proactive planning and organizational talents.
Overview
6
6
years of professional experience
Work History
Clinical Operations Manager
Alvotech
06.2023 - Current
- Company Overview: Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines
- Manage clinical trials from inception to completion, ensuring adherence to protocols and timely submission of accurate reports
- Coordinate multidisciplinary team meetings to discuss complex cases and devise individualized treatment plans for patients
- Perform activities to keep the study on budget, on time and with the highest standard of quality
- Ensure regulatory compliance with timely audits, thorough documentation, and prompt corrective actions
- Communicate effectively with staff members, physicians, and patients, employing active listening and interpersonal skills
- Organize F2F Investigator Meetings
- Maintain study TMF up to date ad inspection ready
- Develop and implement internal SOPs and Work Instructions (WIs)
- Perform Vendor Selection and contribute to negotiation of budget and scope of work
Clinical Operations Coordinator
Alvotech
02.2021 - 06.2023
- Managed vendor relationships to ensure timely delivery of supplies and services necessary for efficient clinical operations
- Ensured regulatory compliance by diligently tracking documentation and maintaining up-to-date knowledge of industry standards
- Facilitated strong communication among team members, fostering a collaborative work environment that increased productivity
- Collaborated with other departments within the organization to share best practices and ensure consistent application of policies across all areas of clinical operations
- Maintained accurate records of trial data, ensuring data integrity and timely submission to regulatory authorities
- Provided support to investigators in managing large-scale clinical research projects, achieving project milestones on time and within budget constraints
- Supported start-up and conducting phase of a global phase III clinical trial in ophthalmology (South America, Europe, Asia)
- Oversaw Site Feasibility and Selection process
- Oversaw and maintained Trial Master File (TMF) in strict compliance with ICH/GCP and internal SOPs
- Conducted on-site Sponsor co-monitoring and booster visits
- Organized on site and remote Investigator Meetings
Clinical Trial Assistant
Alvotech
03.2020 - 02.2021
- Supported the Project Managers in three global biosimilar phase III studies that achieved the key milestones in expected timelines (Rheumatoid Arthritis, Psoriasis)
- Administrative support in the maintenance of study-related documentation
- Responsible for maintaining Sponsor’s TMF
- Responsible for the registration and update of studies on CT.gov
Junior Clinical Trial Assistant
Alvotech
07.2019 - 03.2020
- Supported Clinical Operation Team in meetings, slides, agenda, and minutes preparation
- Support edProject Manager in timelines and report review
- Supported the Project Manager during Sponsor co-monitoring visits
- Provided administrative support to Clinical Operations team
Education
PhD - Pharmacology, Toxicology, Human Development and Movement Sciences
Alma Mater Studiorum – University of Bologna
03.2020
Professional Master’s Degree - chemical and Toxicological Forensic Sciences
Alma Mater Studiorum – University of Bologna
10.2016
Biological License -
Alma Mater Studiorum – University of Bologna
11.2015
M.S. Degree - Health Biology
Alma Mater Studiorum – University of Bologna
03.2015
B.Sc. Degree - Biological Sciences
Alma Mater Studiorum – University of Bologna
07.2012
Skills
- Clinical trial management
- Interpersonal communication
- Empathy, work ethic, and adaptability
- Creativity and writing
- Attention to details
- Investigator relations
- Computer literacy
- Problem Solving
Training
- Trial Master File key requirements and the essentiality of documents, Brookwood Global, 01/01/20
- Overview Of The Content & Impact Of The New Ema & Fda Guidance On Computerised Systems & Electronic Data In Clinical Trials, Brookwood Global
- Risk Management Training, Brookwood Global
- EU Clinical Trial Regulation Training, Brookwood Global
- Working in CRO’s TMF, Phexglobal
- ICH-E6 Requirements for Vendor Oversight, The Avoca Group
- GLP Training, Alvotech Swiss - AG
- Managing Regulatory Inspections (GCP), Alvotech Swiss - AG
- ICH-GCP (R2) Advanced Training, Alvotech Swiss – AG
- Clinical research Training Course “Missione CRA”, ClinOpsHub, Yghea CRO
Gymnastics, reading, cooking
I have been a gymnast and a gymnastic teacher for majority of my life.
I am a curious person, thus I love reading books with some historical background or listening podcast on known and unknown stories.
I like cooking for sharing, I love preparing lunches or dinners with friends and family.
Languages
English
Advanced (C1)
Spanish
Beginner (A1)
Timeline
Clinical Operations Manager
Alvotech
06.2023 - Current
Clinical Operations Coordinator
Alvotech
02.2021 - 06.2023
Clinical Trial Assistant
Alvotech
03.2020 - 02.2021
Junior Clinical Trial Assistant
Alvotech
07.2019 - 03.2020
Professional Master’s Degree - chemical and Toxicological Forensic Sciences
Alma Mater Studiorum – University of Bologna
Biological License -
Alma Mater Studiorum – University of Bologna
M.S. Degree - Health Biology
Alma Mater Studiorum – University of Bologna
B.Sc. Degree - Biological Sciences
Alma Mater Studiorum – University of Bologna
PhD - Pharmacology, Toxicology, Human Development and Movement Sciences
Alma Mater Studiorum – University of Bologna
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