Experience

ProSciento, Inc.

• United States
• Research Services
• 100 - 200 Employee

• Senior Director Business Operations

  • Jun 2023 - Present

  San Diego, California, United States

• Director, Study Start-up

  • May 2022 - Jun 2023

• Associate Director, Study Start Up

  • Jan 2021 - Jun 2022

  San Diego, California, United States Responsible for the effective operations and delivery of the site activation deliverables within the assigned projects. Providing strategic direction and creating a high-performance culture through leadership, line management, coaching and development to achieve delivery of site activation service targets/measures (e.g. cost, quality, time) and the effective development & implementation of systems, processes and policies for the group. Fosters a culture that drives customer focused solutions… Show more Responsible for the effective operations and delivery of the site activation deliverables within the assigned projects. Providing strategic direction and creating a high-performance culture through leadership, line management, coaching and development to achieve delivery of site activation service targets/measures (e.g. cost, quality, time) and the effective development & implementation of systems, processes and policies for the group. Fosters a culture that drives customer focused solutions, personal accountability, and delivery excellence. Also responsible for the clinical systems of record (electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), etc.) with a focus on optimizing their utility to drive visibility into project and departmental performance. Performs duties in accordance with company’s values, policies and procedures.

• Clinical Project Manager II

  • Sep 2017 - Jan 2021

  Grande San Diego e Região, Estados Unidos



PPD

• United States
• Research Services
• 700 & Above Employee

• Clinical Team Manager

  • Sep 2015 - Sep 2017

  Grande San Diego e Região, Estados Unidos • Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial • Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables • Manage clinical budget; escalate out-of-scope activities to the appropriate… Show more • Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial • Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables • Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for inclusion in a contract modification Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory & Start Up Associate Manager

  • Mar 2014 - Aug 2015

  Sao Paulo/SP Brasil and San Diego/CA USA • Manage Start Up Team for Latin and North America, Europe, Africa and Asia-Pacific. • Manage the execution of Start Up (including pre-award/bid defense activities) for assigned projects in accordance with the agreed RSU strategy. • Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver… Show more • Manage Start Up Team for Latin and North America, Europe, Africa and Asia-Pacific. • Manage the execution of Start Up (including pre-award/bid defense activities) for assigned projects in accordance with the agreed RSU strategy. • Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. • Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required. • Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. • Work with Quality Management to ensure appropriate quality standards for the duration of the project. • Mentor and coach colleagues. • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information • Proactive role in developing long standing relationships with preferred Quintiles customers. • Deliver presentations/training to clients, colleagues and professional bodies, as required

• Regulatory & Start Up Lead

  • May 2012 - Jun 2014

  São Paulo e Região, Brasil • Manage Start Up Team for Latin America, Africa and Asia-Pacific. • Manage the execution of Start Up (including pre-award/bid defense activities) for assigned projects in accordance with the agreed RSU strategy. • Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project… Show more • Manage Start Up Team for Latin America, Africa and Asia-Pacific. • Manage the execution of Start Up (including pre-award/bid defense activities) for assigned projects in accordance with the agreed RSU strategy. • Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. • Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required. • Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. • Work with Quality Management to ensure appropriate quality standards for the duration of the project. • Mentor and coach colleagues. • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information • Proactive role in developing long standing relationships with preferred Quintiles customers. • Deliver presentations/training to clients, colleagues and professional bodies, as required



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Country Clinical Operations Associate - Coordinator

  • Jul 2010 - May 2012

  Responsible for the coordination and support to multiple clinical teams to ensure that deliveries and timelines are within the quality standard and following ICG-GCP and international rules.

• Clinical Research Associate

  • May 2009 - Jul 2010

  São Paulo, Brazil Responsável pelo gerenciamento dos centros como monitor de estudo desde a fase de seleção até a fase de fechamento do estudo, através da constante integração entre a equipe da Roche e a equipe do centro.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Aug 2008 - May 2009

  São Paulo, Brazil



PPD

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • May 2005 - May 2008

  São Paulo, Brazil