Sara Amodeo

• Summary of responsibilities:
  - Ensure clinical delivery of assigned projects in compliance with GCP, internal SOPs, regulatory and customer requirements.
  - Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
  - Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
  - Ensure clinical quality delivery by identifying quality standards/requirements and overseeing management of clinical quality issues.
  - Manage clinical aspects of Project Finances.
  - Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
  - Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
  - Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders, as per project scope requirements.
  - Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance, and project-related trainings.
  Mentor and coach new peers as they assimilate into this role.
• Main achievements:
  - Acted as regional Clinical Lead from December 2021 to June 2024 in the context of 2 large phase III studies (around 900 patients and 30 countries each) in SNC indication (Multiple Sclerosis), maturing experience in overseeing several countries in LATAM, EMEA, Australia, and APAC regions, covering multiple global tasks including vendor oversight.
  - Since August 2024 acted as global CL in an oncologic (squamous cell carcinoma of the head and neck) phase III study (166 patients, 26 countries) driving the study to a successful DBL and site closures within expected timelines and budget.
  - Currently, gCL is in phase I study in oncology (Advanced Solid Tumors) in the start-up phase.

• Summary of responsibilities:
  - Head of the Italian office with functional management and resources coordination of up to 6 people in different roles (Accounts, CTAs, CRAs, Regulatory Specialists) as well as outsourced consultants. Responsible for local human resources and office accountability.
  - Responsible for overall clinical operations activities with a quality-first focus and strong leadership, managing clinical trials from feasibility to close out, covering phase II-III clinical trials in Oncology, Women's Health, Neurology, Pain, Cardiology, Otolaryngology, Constipation, COVID-19 indications.
  - Management of all aspects of regulatory affairs in the Italian office.
  - Management of all CRA activities including supervision and training. Mentor for junior CRAs to achieve Clinical Monitor certification as per Italian MD 15Nov2011.
  - Responsible for business development within Italy and Switzerland for SCOPE (networking/outreach, proposals writing and bid defense.
• Main achievements:
  - Applied all procedures with emphasis on adapting local branch according to Italian law.
  - Planned and formulated local SOPs to drive maximum compliance of CRO with MD 15NOV2011.
  - Ensured adherence of all necessary steps to work safety rules in line with Italian legislation 81/08.
  - Attained lucrative position in center of Milan city, leading to complete refurbishment of all operations.
  - Transformed Italian seat from representative office of parent company to limited liability company with Italian legal personality (SRL).
  - Expanded company by consistently raising number of employees with focus on maintaining stable team with minimal turnover rate and winning new projects.

• Summary of responsibilities:
  - Identification of investigative sites for new studies and initial contacts performing.
  - Conduction and coordination of pre-study, initiation, monitoring, and closeout visits at the sites according to the CRO/Sponsor’s SOPs and the GCP (indications: Parkinson, Epilepsy, Polymyalgia Rheumatica, Opiod Induced Constipation, Oncology).
  - Ensuring the completeness of the investigator site file (ISF) and collection of the essential documents on-site for filing in the in-house trial master file (TMF).
  - Documentation filing and management of the local working file (LWF).
  - Training of new study team members in study related procedures and ICH-GCP, supervision of inexperienced CRAs and performing co-monitoring visits.
  - Preparation of the Ethics Committee and Competent Authority submission documentation (initial submissions, substantial amendments submissions, not substantial amendments notifications) and following the submission/notification process until the EC/CA approval relaying with “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali” (OsSC).
  - Negotiation of the financial agreements with the sites.
  - Translation of the study related documents (EC/CA submission letters, EC approval minutes, Administrative Resolutions, site main correspondence) and transmission to the TMF.
  - Assistance during the identification of local vendors and activities to be locally subcontracted.
• Main achievements:
  - Managed two molecules of the same client, including antiepileptic drug as well as a medication for the treatment of Parkinson disease through clinical trials from phase II to phase III until marketing authorization achievement.
  - Achieved customer satisfaction and retention by fulfilling immediate needs and demands.

• Summary of responsibilities:

Local monitoring of clinical trials in the Central Nervous System therapeutic area: conduction of pre-study, initiation, monitoring, and closeout visits at the sites according to CRO SOPs and GCP

• Summary of responsibilities:
  - Local monitoring of clinical trials (Oncology area: breast cancer, gastric cancer, lung cancer, colon cancer).
  - Participation in the protocols drafting.
  - Design and implementation of electronic CRFs.
  - Preparation of the Ethics Committee and Competent Authority submission documentation and following the submission/notification process until the EC/CA approval relaying with “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali” (OsSC).
  - Documentation filing and management of the Trial Master File.
  - Participation in the development of the standard operating procedures (SOP) in the area of Clinical Operation.
• Main achievements:
  - Tracked execution of phase II and III no profit studies in Italy mainly in oncology domain. Managed and submitted documents to various stakeholders, including Ethics Committees and Competent Authorities. Finalised contract negotiations with clinical sites. Provided support in proper management of protocol, ICF, and CRF development. Planned and implemented local SOPs by applying best practices.
  - Earned certification of clinical monitor (CRA) according to the Italian MD 15/11/2011.