Claudia Santangelo Email & Phone Number

As part of Global Site Engagement Team, working as clinical trial expert, facilitating the efficient implementation of Takeda’s portfolio. Acting as the local face of Takeda for site relationships and engagement, supporting Clinical Operations study teams with countries and sites identification, selection, startup and recruitment activities across all Takeda CDO therapeutic areas. Responsible for ensuring the local implementation of the site relationship management strategy, working collaboratively with Stakeholders to foster partnership with KOL, Investigators and other meaningful actors for the clinical trials implementation, aiming to shorten study start-up timelines, enhance site performance and increase delivery of life transforming drugs. Collaborate with local Medical Affairs team to conduct mutual site exchanges to create a “OneTakeda” approach and support site and company success. Deliver local intelligence, insights, and context in real time to guide trials strategies. Works collaboratively with CRO partners as well to ensure effective study delivery.

Working for Sanofi

Milan, Lombardy, Italy

Managed phase I, II, III international studies in the following therapeutic areas: Oncology (Basket trials for many different solid tumors, Malignant Pleural Mesothelioma, Urothelial Carcinoma), Intesive Care, Cardiovascular (Diabetic Nephropathy, CKD, Heart Failure).Worked in studies involving one of the flagship molecule for the company, responsible for one of the global top enroller site. Fully responsible for site management from the site selection till close out including regulatory authorities and Ethics Committees submission, budget and contract negotiation; responsible for eTMF completeness and accuracy, performing periodic quality review and quality checks.Performing mentoring activities for junior CRAs, supporting study managers in country oversight, reviewing visits reports, training of Jr CRAs both in study specific procedures and GCP, performing on site assessments visits, conducting monthly team meeting, identify escalate and facilitate resolution of study-specific issues.Responsible for conducting feasibility process, managing relationships with external Vendors, ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables.Close work with Medical Affairs in designing the appropriate strategy to ensure site engagement and commitment and developing initiatives to enhance patient recruitment .Member of an international working group for the set up and the implementation of risk-based monitoring maturation project.Successfully faced on site GCP audits with no major findings.

Sponsor dedicated to Bayer

Main responsibilities:• Management of designated clinical trials including investigator selection, analysis of potential patient recruitment, supporting Ethics Committee submissions to ensure timely and successful outcome.• Ensuring appropriate strategies are in place for an effective and successful patients recruitment and retention • Conducting site visits to assess compliance with Sponsor Standard Operating Procedures, ICH- GCP Guidelines, protocol requirements, national and international regulations, monitoring plan • Ensuring high quality and accuracy of data collected from investigational sites • Analyzing issues and using judgment to make decisions for proactive resolution and/or escalation when needed• Joining bid defense meeting as country CRAs representativeTherapeutic Areas: CNS (Alzheimer Disease), Onco-Hematology (Mantle Cell Lymphoma), Immunology (Systemic Lupus Erythematosus), Dermatology (Atopic Dermatitis) Phase II, III and IV studies.

In phase II and phase III clinical trials CRA responsible for: pre-study, initiation, monitoring and close out visits; prepararation of essential documents and support in drug release process, contracts negotiation, study files management, remote site management. Therapeutic areas: Nephrology (Anemia in Chronic Kidney Disease), Oncology (Non Small Cell Lung Cancer), Metabolic Disorders (Type II Diabetes), CNS (Huntington Disease).

Master Mema- Management Farmaceutico Medical Scientific Liason E Medical Advisor

Programma Scienziati In Azienda

Activities and Societies: Pharmaceutical Marketing, Clinical Trials, Regulatory Affairs, Health Economy

Biological Sciences

Graduated with honours. Research activity in nutrition area: study of the comparative efficacy of sulforafane and physical exercise.