Raquel Schneid Navarro
New Jersey,USA
Summary
Clinical Research Professional with over 15 years’ Oncology industry experience at Local, Regional and Global Level Team leader managing associates as 1st line manager within Local/Global function for clinical trials and related activities and external vendor operations Leader focused on people development to ensure results delivery with quality and efficiency. Developed end-to-end overall strategic planning and execution of multi-national Managed Access and Post trial Access programs while establishing a centralized patient access model for Global Medical Affairs Oncology/Pharma. Focused strengths leading medical educational programs, scientific advisory boards, congresses, and trainings with key medical experts. Key expertise in quality initiatives, HA audit and inspection readiness, process improvement and SOP creation, training, and development.
Overview
10
10
years of professional experience
Work History
Global Medical Affairs Associate Director, Managed Access/PTA
Novartis Pharmaceutical
2019.05
- Responsible for coordinating and providing oversight and transparency on Managed Access Programs (MAPs) across Oncology/Pharma Medical Affairs
- Provide an oversight on Global Managed Access Programs (MAPs)/Post Trial Access (PTA) system data accuracy, milestones, reporting, budget
- Responsible for planning, execution and management of MAP/PTA Clinical Operations activities in accordance with global strategy to ensure timely and efficient access to drugs to patients
- Identify operational efficiencies and best practices amongst the MAP portfolio within current GOP
- Act as Subject Matter Expert for all MAPs: Act as the central point of escalation for all MAP-related issues and potential deviations
- Identify requirement of preparation of new MAP Treatment Plan and coordinate corresponding activities with Franchise Team
- Liaise with Medical Responsible on MAP request approval/rejection and Partner to ensure planning, execution, and reporting of Managed Access and PSDS with high quality, adequate resources, timely and cost-effective execution
- Track decision as well as overall MAP strategy (inclusion/exclusion of disease types)
- Partner with Global Clinical Supply to support MAP drug supply process as needed
- Ensure annual MAP Treatment Plan updates are prepared as applicable
- Drive the operational excellence for the MAP portfolio across OMA through KPI and metrics; Identify trends on the outcomes of metrics and KPIs and develop mitigation plans as required
- Support process simplification and knowledge sharing, operational excellence, performance, and quality and drive a compliance mind set
- Enables a collaborative and empowered organization that can navigate in a matrix environment and adjust quickly to business needs
- Participate in cross-functional MAP Governance Board and MAP related initial.
Local Clinical Research Head- Oncology
Novartis Biociências S/A
2016.05 - 2019.04
- Responsible for the management and oversight of Novartis Oncology Global Medical Affairs operational activities and team in Brazil
- Managing local studies: Start-up activities such as initial proposal, protocol design, revision of study protocols; elaboration and review of study related materials, hiring and management of CROs and vendors, site feasibility assessments etc
- Overall study conduct (logistics, budget and contract negotiation, drug supply management, data management, monitoring, database lock timelines achievement and Close-out activities including development study report and publications
- Supporting the drafting review and implementation of local medical SOPs
- Responsible for the implementation and evaluation of quality controls and KPIs for all the local clinical operations activities (including external vendors)
- Serving as the MAP and IIT Champion for Brazil, liaising with the Global Governance Office regularly, reviewing and implementing relevant procedures, delivering trainings to other CPO teams/line functions, and managing all drug supply activities
- Responsible for the implementation and evaluation of quality controls and KPI in the local operations and vendors
- Member of the Local Quality Team in the Country Organization, preparing teams and participating in internal audits and HA inspections.
Regional Clinical Operations Manager LACan (GMA) - Ad interim
Novartis Biociências S/A
2016.08 - 2017.08
- Supporting the management of local studies, managed access/compassionate use programs, and Post trial Access activities in the region
- Responsible for development and maintenance of relevant communication across the region as well as flagging to the Regional Leadership team issues, risks and initiatives involving medical and clinical operations in the region.
Clinical Research Coordinator- Oncology
Novartis Biociências S/A
2014.05 - 2016.05
- Management of Local Medical Affairs activities including local trials, compassionate use programs, IITs, post-trial drug access, vendors and CRO contracts
- Conducting co-monitoring visits, and responsible for review of monitoring visit reports and CRA support; participation in sponsor audits
- Responsible for training, quality control and local SOP review.
Medical Science Liaison - Oncology
Novartis Biociências S/A
2012.08 - 2014.05
- Development of partnerships with investigators, opinion leaders and healthcare professionals for evidence generation, scientific exchanges (incl
- Pipeline presentations) and education; managing scientific projects and publication activities
- Involvement in clinical trial activities – feasibility assessment, supporting patient recruitment and identification of potential sites
- Active participation in medical educational programs, scientific advisory boards, congresses and trainings
- Providing scientific support to marketing teams.
Monitoring Clinical Research - CRA in Oncology
Novartis Biociências S/A
2009.01 - 2012.07
- Monitoring multiple global Oncology studies with sites in Brazil
- Conducting operational feasibility assessments in a cross-functional team (CRAs, MSLs and Medical Advisors)
- Management of study start-up activities with CRAs/CTAs and regulatory department, identification, qualification and selection of sites; conducting training on recruitment strategies, ICH-GCP, study procedures, sample management, CRF system etc
- Conducting local investigator meetings
- Served as Lead CRA of several studies - interacting closely with the global clinical team and other CRAs
- Management of local enrollment plans and overall study conduction (logistics, conduct and study close activities)
- Mentoring and coaching of new CRAs; performing co-monitoring visits
- Responsible for the overall user training of eCRF system in Brazil for CRAs and research sites.
Education
Principles and Practice of Clinical Research -
Harvard Medical School
12.2014
Business MBA -
Business School São Paulo, Brazil
06.2013
Post Graduation - Pharmaceutical Medicine -
São Paulo Federal University, Brazil
12.2008
Bachelor Degree - Industrial Pharmacist -
São Judas Tadeu University, Brazil
12.2005
Skills
- Clinical Research Operations & Project Management
- Team Leadership
- People Development
- Strategic Planning
- Managed Access & Post trial Programs
- Medical Education & Scientific Advisory Boards
- Inspection & Audit Readiness
- Process Improvement and SOP Creation
- Key relationship management
- Decision-Making
- Critical Thinking
Publications
Evaluation of the Use, Prescription and Dispensation of Generic Drugs in the city of São Paulo - Brazil, Revista do Farmacêutico, June/July 2003
Training
- M1- Lead the Way, 10/2018, NJ/USA
- Project Management Course, 08/04/2011
- Master Mind - Full Program - Leadership, Strategy, Negotiation and Public Speaking, 05/2011
- Communication and Presentation Skills, 11/18/2010
- Novartis GMO ICH GCP 3-Day Course Attendance Sheet, 04/13/2009, S.Paulo, Brazil
Accomplishments
- Global Development Star Award 2020 - issued by resilience in unprecedented time
Recognized by Novartis Global Head Drug Development by work on COVID-19 Managed Access Program team an the prevision of Novartis Products to COVID-19 patients
Timeline
Global Medical Affairs Associate Director, Managed Access/PTA
Novartis Pharmaceutical
2019.05
Regional Clinical Operations Manager LACan (GMA) - Ad interim
Novartis Biociências S/A
2016.08 - 2017.08
Local Clinical Research Head- Oncology
Novartis Biociências S/A
2016.05 - 2019.04
Clinical Research Coordinator- Oncology
Novartis Biociências S/A
2014.05 - 2016.05
Medical Science Liaison - Oncology
Novartis Biociências S/A
2012.08 - 2014.05
Monitoring Clinical Research - CRA in Oncology
Novartis Biociências S/A
2009.01 - 2012.07
Principles and Practice of Clinical Research -
Harvard Medical School
Business MBA -
Business School São Paulo, Brazil
Post Graduation - Pharmaceutical Medicine -
São Paulo Federal University, Brazil
Bachelor Degree - Industrial Pharmacist -
São Judas Tadeu University, Brazil
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