Experience

Endosane Pharmaceuticals

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager Development Clinical Operations and Quality

  • Jun 2022 - Present



Linical

• Japan
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Operations Manager

  • Mar 2016 - Jun 2021



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Manager Clinical Operations-Late Phase

  • Jan 2014 - Feb 2016

  Manage and develop Site Management Associates (SMAs) and Operational Site Managers (OSMs) to ensure high quality work performance and retention of high quality employeesResponsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligationsResponsible for hiring SMAs and OSMs in Europe and Asia Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management. Leading task forces to implement process improvement initiativesProvides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts to the budget



IQVIA

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

• Associate Manager

  • Sep 2011 - Dec 2013

  Line Manager/Site Visit Report Quality Reviewers Team Quintiles GmbH, GermanyManage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management

• Associate Clinical Research Specialist

  • Dec 2010 - Aug 2011

  Site Visit Report Quality ReviewerQuintiles GmbH, Germany Monitor and maintain a high standard quality of the clinical component of Site Visit Reports, focusing on patient safety data integrity and regulatory compliance Develop and implement necessary communication, training and escalation pathways. Use existing global systems and processes Cooperate closely with Project Leaders and CRA's to ensure quality, standardization and timeline adherence for all monitoring visit reports across assigned studiesHighlight relevant trends, and related risk factors to the study team to optimize the quality of project delivery.



Quintiles GmbH

• Clinical Team Lead ((Maternity/Parental Leave from May2009-Sep2010)

  • Sep 2008 - May 2009

  Provide ongoing support to the client. Establish study tools and processes.Contribute to the risk management plan from a local perspective and coordinate issue escalation and resolution with the global Project Manager.Identify quality issues within the study through regular communication with client.Coordinating CRF/ADR and query flow. Tracking of enrolment, CRF and ADR and regular status reporting (CRF shipment to DM)Participating at the local investigator meetings Provide ongoing support to the client. Establish study tools and processes.Contribute to the risk management plan from a local perspective and coordinate issue escalation and resolution with the global Project Manager.Identify quality issues within the study through regular communication with client.Coordinating CRF/ADR and query flow. Tracking of enrolment, CRF and ADR and regular status reporting (CRF shipment to DM)Participating at the local investigator meetings



IQVIA

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

• Sr. Clinical Research Associate

  • Feb 2006 - Aug 2008

  Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practiceProvide monitoring visits and site management for a variety of protocols, sites and therapeutic areasAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issuesEvaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolutionCreate and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentationAct as a mentor for new clinical staff

• Clinical Research Associate

  • Jul 2004 - Jan 2006

  Provide support to the Sr. Clinical Research Associates (Co-Monitoring) in one large cardiovascular clientPerform site monitoring and close-out visits in accordance with contracted scope of work and good clinical practice for one large cardiovascular trial Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations



Merz Therapeutics

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Representative

  • Oct 2002 - Jun 2004

  Work strategically to increase the awareness and use of a company’s pharmaceutical and medical products in settings such as general practices and hospitalsMake presentations and organize group events for healthcare professionals Work strategically to increase the awareness and use of a company’s pharmaceutical and medical products in settings such as general practices and hospitalsMake presentations and organize group events for healthcare professionals



DaimlerChrysler AG

• Trainee

  • Jan 2002 - Apr 2002

  Collected, processed and assessed the data for a groundwater model for the site Sindelfingen Developed a user manual for the modeling of the underlying database in coordination with the consulting engineers GZA in Livonia/Michigan, USA Collected, processed and assessed the data for a groundwater model for the site Sindelfingen Developed a user manual for the modeling of the underlying database in coordination with the consulting engineers GZA in Livonia/Michigan, USA



University of Buenos Aires

• Argentina
• Higher Education
• 700 & Above Employee

• Assistant to the Chef Investigator

  • Apr 1999 - Jun 2001

  Studied the parasitic relationship between a mollusk gastropod and a pea crab Studied the parasitic relationship between a mollusk gastropod and a pea crab