Experience

CEBIS

• United States
• Research Services
• 1 - 100 Employee

• Global Director - Drug Development Strategy

  • Oct 2023 - Present

  Teresa’s professional network includes people in the pharmaceutical industry in both the American continent , Europe and Intercontinental regions . for our successful expansion it is critical her expertise working for biotech businesses and that she is actively involved in South American affairs. To expand our operations into the business zones of Israel, South America and Japan because these zones are beneficial to our company. Teresa’s professional network includes people in the pharmaceutical industry in both the American continent , Europe and Intercontinental regions . for our successful expansion it is critical her expertise working for biotech businesses and that she is actively involved in South American affairs. To expand our operations into the business zones of Israel, South America and Japan because these zones are beneficial to our company.



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Global Site Management Lead

  • May 2020 - Oct 2023

  Single point of accountability for the Clinica Site Management (CSM) study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables to completion by targeted timelines and within budget for their assigned studies. Primary SMM Point of Contact and interface for Study Team and CSM in their assigned studies… Show more Single point of accountability for the Clinica Site Management (CSM) study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables to completion by targeted timelines and within budget for their assigned studies. Primary SMM Point of Contact and interface for Study Team and CSM in their assigned studies. Accountable for management of complex and/or large single study or multiple studies, conducted across multiple countries. Assists the Therapeutic Area Lead in strategic planning and driving timely completion of SMM deliverables at global level for the programs in their assigned TA(s)/indications, in alignment with key stakeholders across the organization. Show less Single point of accountability for the Clinica Site Management (CSM) study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables to completion by targeted timelines and within budget for their assigned studies. Primary SMM Point of Contact and interface for Study Team and CSM in their assigned studies… Show more Single point of accountability for the Clinica Site Management (CSM) study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables to completion by targeted timelines and within budget for their assigned studies. Primary SMM Point of Contact and interface for Study Team and CSM in their assigned studies. Accountable for management of complex and/or large single study or multiple studies, conducted across multiple countries. Assists the Therapeutic Area Lead in strategic planning and driving timely completion of SMM deliverables at global level for the programs in their assigned TA(s)/indications, in alignment with key stakeholders across the organization. Show less


Celgene
• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Senior Specialist PM Medical Projects

  • Oct 2019 - May 2020

Looking for new and challenging opportunities
• Senior Clinical Research/Operations Professional

  • Sep 2019 - Oct 2019


Merck Group

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Clinical Research Manager -Site Relationship & Operations Lead

  • Apr 2013 - Oct 2019

  • Accountable for all aspects for the management of local and/or regional company-sponsored studies, Global Phase l- IV trials , Investigator sponsored studies, including study plans, timelines, resources, Budget , problem identification and resolution, to ensure timely delivery of completed study reports • Line Manager for assigment team including , coaching , training, development , compensationa and performance management • Accountable for building and managing Investigator/… Show more • Accountable for all aspects for the management of local and/or regional company-sponsored studies, Global Phase l- IV trials , Investigator sponsored studies, including study plans, timelines, resources, Budget , problem identification and resolution, to ensure timely delivery of completed study reports • Line Manager for assigment team including , coaching , training, development , compensationa and performance management • Accountable for building and managing Investigator/ site staff / KOL , relationships whilst overseeing site-level feassibility, study start-up, conduct and close out activities outsourced to a CRO partner for global programs across all therapeutic areas within the Merck pipeline in countries as Spain, ,Israel, ( previously EEC, Greece, etc), acting as interface and keeping a proactive communication between the global clinical operations and local organization . • Oversight performed in a combination with sites visits and routine meetings with the CRO, country management team, data review & trend analysis, etc • Ensuring compliance with local/regional guidelines, ICH / GCP as well as alignment of systems and processes to Company and global standards (performance, quality, timelines) • Working with multi-functional teams addressing operational efficiencies/improvements, working procedures, with the CRO, internal ( drug safety, clinical trial supplies, legal, etc) and external ( CROs, providers, Cooperative group, independent sponsors, etc.) stakeholders • Ensuring Management of independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment • Support local organization in delivering local medical strategy across the portfolio within own region providing an interface with regional/local organizations (Medical Affairs/ compliance/ legal, RA, etc ) and ensuring alignment on trial strategy Show less • Accountable for all aspects for the management of local and/or regional company-sponsored studies, Global Phase l- IV trials , Investigator sponsored studies, including study plans, timelines, resources, Budget , problem identification and resolution, to ensure timely delivery of completed study reports • Line Manager for assigment team including , coaching , training, development , compensationa and performance management • Accountable for building and managing Investigator/… Show more • Accountable for all aspects for the management of local and/or regional company-sponsored studies, Global Phase l- IV trials , Investigator sponsored studies, including study plans, timelines, resources, Budget , problem identification and resolution, to ensure timely delivery of completed study reports • Line Manager for assigment team including , coaching , training, development , compensationa and performance management • Accountable for building and managing Investigator/ site staff / KOL , relationships whilst overseeing site-level feassibility, study start-up, conduct and close out activities outsourced to a CRO partner for global programs across all therapeutic areas within the Merck pipeline in countries as Spain, ,Israel, ( previously EEC, Greece, etc), acting as interface and keeping a proactive communication between the global clinical operations and local organization . • Oversight performed in a combination with sites visits and routine meetings with the CRO, country management team, data review & trend analysis, etc • Ensuring compliance with local/regional guidelines, ICH / GCP as well as alignment of systems and processes to Company and global standards (performance, quality, timelines) • Working with multi-functional teams addressing operational efficiencies/improvements, working procedures, with the CRO, internal ( drug safety, clinical trial supplies, legal, etc) and external ( CROs, providers, Cooperative group, independent sponsors, etc.) stakeholders • Ensuring Management of independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment • Support local organization in delivering local medical strategy across the portfolio within own region providing an interface with regional/local organizations (Medical Affairs/ compliance/ legal, RA, etc ) and ensuring alignment on trial strategy Show less



Praxis Pharmaceutical

• Colombia
• Medical and Diagnostic Laboratories
• 1 - 100 Employee

• International Clinical Project Manager

  • Nov 2011 - Mar 2013

  Responsible for: International high-level planning of clinical development programs within the Clinical Development Deprtament ; operationalizing, tracking and management of approved clinical development studies concerning milestones, costs, resources, and quality; early detection of possible problems and risks , proposing and implementing solutions; providing accurate timely and accessible information to customers and stakeholders and facilitating continuous improvement process in… Show more Responsible for: International high-level planning of clinical development programs within the Clinical Development Deprtament ; operationalizing, tracking and management of approved clinical development studies concerning milestones, costs, resources, and quality; early detection of possible problems and risks , proposing and implementing solutions; providing accurate timely and accessible information to customers and stakeholders and facilitating continuous improvement process in clinical development , providing the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Show less Responsible for: International high-level planning of clinical development programs within the Clinical Development Deprtament ; operationalizing, tracking and management of approved clinical development studies concerning milestones, costs, resources, and quality; early detection of possible problems and risks , proposing and implementing solutions; providing accurate timely and accessible information to customers and stakeholders and facilitating continuous improvement process in… Show more Responsible for: International high-level planning of clinical development programs within the Clinical Development Deprtament ; operationalizing, tracking and management of approved clinical development studies concerning milestones, costs, resources, and quality; early detection of possible problems and risks , proposing and implementing solutions; providing accurate timely and accessible information to customers and stakeholders and facilitating continuous improvement process in clinical development , providing the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Show less


Quintiles
• Spain
• Associate Director SSU Spain & Portugal

  • Oct 2008 - Apr 2011


GlaxoSmithKline

• United States
• Investment Management

• Medical Operations Advisor

  • Mar 2007 - Sep 2008

  Quality and Outsourcing Quality and Outsourcing


Trial Form Support
• Spain
• Security and Investigations
• 1 - 100 Employee
• CRO Manager for GlaxoSmithKline

  • Sep 2006 - Mar 2007


Discovery Labs

• United States
• Real Estate
• 1 - 100 Employee

• International GCP Auditor

  • 2004 - 2006

• International Clinical Project Manager

  • 2003 - 2004


AstraZeneca
• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Clinical Research Cordinator

  • 2000 - 2002