Ana Paula Basso Rossi

Responsible for the Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers hiring, training, development, and assignment to ensure adequate and timely portfolio execution.
Responsible for CPMs, SSO Feasibility Managers and SSO Site Partnership Managers compliance of study management activities and for the delivery of study milestones, in close collaboration with the CRA Mangers/ FSP line managers and aligned with Global and local medical strategy, in… Exibir mais

Responsible for the Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers hiring, training, development, and assignment to ensure adequate and timely portfolio execution.
Responsible for CPMs, SSO Feasibility Managers and SSO Site Partnership Managers compliance of study management activities and for the delivery of study milestones, in close collaboration with the CRA Mangers/ FSP line managers and aligned with Global and local medical strategy, in Brazil.
Responsible for overall portfolio execution related performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP’s, and local regulations. Exibir menos

CSM Study allocation and workload distribution.
On-boarding and Training support for Brazilian CSM Team (8 internal + 2 FSP).
Oversight of CSM KPIs and study deliverables.
Partnership with CRA Managers, Regulatory, Strategic Operations and CRMA teams to accomplish country deliverables considering the company priorities.
Collaboration with Brazil Country Head on quality plan implementation and follow-up.

Lead feasibility process at regional level for LACAN.
Enable and support discussion about country and site selection and ensure properly documentation, in partnership with local country teams.
Collaborate with and provide insights to Strategic & Planning Feasibility team for an optimal regional strategic planning and feasibility allocation.

Operational management of global studies through planning, executing, and reporting Novartis sponsored clinical trials in Brazil.
Managing assigned clinical trials in Brazil from feasibility to close out (including budgetary control from country and site levels, regulatory flow accountability, local vendor assessments, local supplies management, staff specific training, data flow, issue management, study deliverables.
KAIZEN Lead for Payment & Budget process.
Mentoring of junior CSMs… Exibir mais

Operational management of global studies through planning, executing, and reporting Novartis sponsored clinical trials in Brazil.
Managing assigned clinical trials in Brazil from feasibility to close out (including budgetary control from country and site levels, regulatory flow accountability, local vendor assessments, local supplies management, staff specific training, data flow, issue management, study deliverables.
KAIZEN Lead for Payment & Budget process.
Mentoring of junior CSMs and senior CRAs.
Regional CSM Pilot in LACan. Exibir menos

Oversight activities on CRAs, CTAs and Line Managers (Argentina, Brazil, Chile, Colombia, Peru, Mexico, Guatemala and Dominican Republic) to ensure deliverables with high quality in the conduct of Amgen sponsored trials.
- Close collaboration with FSP LM (Functional Service Provider Line Managers) and Study Managers to gather feedback about study deliverables and team performance to ensure timely and appropriate planning, resourcing and capacity management.
- Trend analysis of quality… Exibir mais

Oversight activities on CRAs, CTAs and Line Managers (Argentina, Brazil, Chile, Colombia, Peru, Mexico, Guatemala and Dominican Republic) to ensure deliverables with high quality in the conduct of Amgen sponsored trials.
- Close collaboration with FSP LM (Functional Service Provider Line Managers) and Study Managers to gather feedback about study deliverables and team performance to ensure timely and appropriate planning, resourcing and capacity management.
- Trend analysis of quality metrics at country and region levels.
- DOM (Development Operations Manager_Sr Manager) support and back up when needed.
- Organize, manage and deliver training in Regional Meetings.
- Preparation and Presentation of the LATAM Operational review meetings with global upper management.

Subject Matter Expert: Translation Process, Data Privacy, Study Deliverables meeting, Quality Oversight Plan and SSU CRA Oversight & Global TMF and local repository.

People Management: Line management of 8 direct reports called SCBAs (Senior Clinical Contracts & Budgets Associate) based in Brazil, Argentina and México.
- Study allocation and workload distribution.
- On-boarding, Training support and performance management for SCBA Team.
- Oversight of financial and SCBA LATAM Hub KPIs and deliverables (regional savings, time for contract negotiations, on-time payments). Exibir menos

Supports Clinical Operations Managers with overseeing operational activities related to planning, executing, and reporting of Amgen sponsored clinical trials in Latin America (Argentina, Brazil, Chile, Colombia & Peru).
- Project management of global and local studies;
- Ensure study milestones achievements;
- Assess site quality and performance.
- eClinical Champion (Clinical Trial Management System)
- Assist in the conduct of feasibility assessments for new clinical… Exibir mais

Supports Clinical Operations Managers with overseeing operational activities related to planning, executing, and reporting of Amgen sponsored clinical trials in Latin America (Argentina, Brazil, Chile, Colombia & Peru).
- Project management of global and local studies;
- Ensure study milestones achievements;
- Assess site quality and performance.
- eClinical Champion (Clinical Trial Management System)
- Assist in the conduct of feasibility assessments for new clinical protocols
- Planning, managing and executing all Amgen sponsored study related activities.
- Promoting operational and scientific excellence within the local group and identifying opportunities and best practices with local and regional partners that will contribute to increased overall operational effectiveness

Individual project management responsibility (studies in regulatory, follow up, extension phase and local portfolio studies required for registry):
- Review and approve monitoring visit reports within SOP-related timelines;
- Tracks local trial implementation, data collection and study reporting;
- Responsible for vendor selection and performance evaluation for local studies ;
- Single point of contact at a project level for local and global staff for studies with sole responsibility;
- Identifies and highlights risk areas (concerning operational readiness, communication and management);
- Ensures CRA gets necessary Therapeutic Areas-related and study-related training;
- CRO Oversight (for fully outsourced model only). Exibir menos

Project / study management of operational activities related to planning, executing, and reporting of Amgen sponsored clinical trials in USA:
- Locally executes, manages and reports on Amgen sponsored studies;
- Single point of contact at a project level for local team(CRAs, CTAs, liaisons and site staff) and Global Study Managers (GSM);
- Monitoring Visit Reports review, develop action plans for issues relating to subject safety, quality, data flow other study related risks;
-… Exibir mais

Project / study management of operational activities related to planning, executing, and reporting of Amgen sponsored clinical trials in USA:
- Locally executes, manages and reports on Amgen sponsored studies;
- Single point of contact at a project level for local team(CRAs, CTAs, liaisons and site staff) and Global Study Managers (GSM);
- Monitoring Visit Reports review, develop action plans for issues relating to subject safety, quality, data flow other study related risks;
- Communication of study progress and issue escalation to upper management and other key stakeholders;
- Assess site quality and performance.

During this placement program (job rotation) I was allocated in the “bone” therapeutic area, being responsible for managing 5 studies of the same molecule. Exibir menos

Project management of oncology clinical trials sponsored by ImClone Global Clinical Operations (Eli Lilly subsidiary) in Latin America Countries (Argentina, Brazil, Mexico, Venezuela, Chile, Guatemala, Colombia, Peru).

People Management: Leader of 1 analyst and 1 trainee (including KPIs follow-up, performance management, coaching).

Project management of oncology clinical trials sponsored by ImClone Global Clinical Operations (Eli Lilly subsidiary) in Latin America Countries (Argentina, Brazil, Mexico, Venezuela, Chile, Guatemala, Colombia, Peru).
Audit participation (follow up and co-auditor).
Mentoring ImClone Brazil staff.
Latin America regulatory submission strategies stakeholder.

Project management focusing on start-up deliverables in Latin America Countries (Brazil, Argentina, México and Venezuela).

Routine Monitoring activities (site selection, site initiation visits, close out visits, archive and financial control).
- Oncology (Head and Neck cancer – Phase II): Monitoring routine, data lock and close out activities (blinded CRA);
- Oncology (Lung cancer – Phase III): Monitoring visits to achieve data lock and close out activities (back up CRA);
- Oncology (Lung cancer – Phase II): Monitoring routine and activities (CRA);
- Neurology (Schizophrenia / Schizoaffective Disorder… Exibir mais

Routine Monitoring activities (site selection, site initiation visits, close out visits, archive and financial control).
- Oncology (Head and Neck cancer – Phase II): Monitoring routine, data lock and close out activities (blinded CRA);
- Oncology (Lung cancer – Phase III): Monitoring visits to achieve data lock and close out activities (back up CRA);
- Oncology (Lung cancer – Phase II): Monitoring routine and activities (CRA);
- Neurology (Schizophrenia / Schizoaffective Disorder – Phase III): Monitoring routine and activities (CRA);
- Diabetes (2 closed trials): Archive review and Archive procedures;
- Cardiology (Acute Coronary Syndrome – Phase II): Waiting regulatory approval, investigator training meeting participation. Exibir menos

Part time trainee as Clinical Trial Assistant:
• Regulatory documents preparation for the Ethics Committee and MOH (ANVISA).
• Document review for Financial Agreement/ Contract.
• Paper TMF maintenance (Master Files, Site Files and Investigator Study Files).
• Document translation.
• Document distribution.
• Participation in feasibility discussions.

Part time trainee as Quality Assurance and Training associate:
• Organization support of the “GCO LA Annual Meeting… Exibir mais

Part time trainee as Clinical Trial Assistant:
• Regulatory documents preparation for the Ethics Committee and MOH (ANVISA).
• Document review for Financial Agreement/ Contract.
• Paper TMF maintenance (Master Files, Site Files and Investigator Study Files).
• Document translation.
• Document distribution.
• Participation in feasibility discussions.

Part time trainee as Quality Assurance and Training associate:
• Organization support of the “GCO LA Annual Meeting 2006” – Costa do Sauípe/BA.
• Training follow-up of Brazilian employees.
• Local SOP binder maintenance. Exibir menos

Consumer attendant service (SAC) (January/2005 – November/2005)
Medical Information Service (INFOC) Trainee (November/2005 - May/2006)
- Consumer Attendance by phone and e-mail (SAC).
- Professional Health Attendance by phone and e-mail (INFOC).
- Preparation of scientific material for health professionals by using scientific platforms (PubMed, Scielo, BIREME, etc.).