Director Clinical Compliance and Inspection Readiness

• Apr 2022 - Present

 Lead and manage (including budget and resources) the Clinical Development (Operations) Compliance and Inspection Readiness Team  Provide expertise and GxP support to Clinical Trials (trial level) and to entire Clinical Development organization (business level) Accountable to evaluate processes, standards and assess compliance risk within clinical trials and all Clinical Development Operations  Initiate and contribute to process improvements activities based on various learning (industry best practices, inspections and audit findings, lessons learned) Evaluate and contribute to the development and implementation of all Clinical Development procedures and standards (including newly created or updated) in particular from compliance perspective, against GxP(s), regulations and industry standard of practice  Regulatory intelligence (monitor, assess and implement regulations) Implement, lead and oversee the Inspection readiness and Inspection Preparation Program Implement and define Key Performance Indicators for vendors and perform compliance and operational vendor oversight in collaboration with Study and Site Management functions and also Vendor Oversight department  Vendor management and oversight  Implement, lead and oversee the Risk Based Quality Management process within the Research and Development Clinical Organization  Implement, conduct and oversee inspection preparation activities – mock inspections/interviews, site inspection preparation visits, sponsor inspection preparation activities  Implement, conduct and oversee Inspection Readiness Programs  Support the management of Clinical Development non-compliance (e.g. deviations, CAPAs, etc.)  Collaborate with the Training department and Process and Document Management and Improvement department Collaborate with Clinical Quality Assurance in audit and inspections, process development, Quality Metrics implementation and oversight within Clinical Development Organization. Show less

Associate Director Clinical Compliance and Inspection Readiness

• Feb 2020 - Apr 2022

 Lead the Clinical Compliance and Inspection Readiness Team Implement, lead and oversee the Inspection readiness and Inspection Preparation Program  Implement, lead and oversee the Risk Based Quality Management process within the Research and Development Clinical Organization - conduct inspection preparation activities – mock inspections/interviews, site inspection preparation visits, sponsor inspection preparation activities (other than mock inspections) Apply clinical compliance principles to clinical trials and provide GCP and as necessary other GxP support for clinical trials Implement, conduct and oversee Clinical Compliance Oversight Programs within Research and Development Clinical Organization Accountable to evaluate processes, standards and assess compliance risk within clinical trials and all Clinical Development Operations Support the management of non-compliances (e.g. deviations, CAPAs, etc.) and ensure enhancement and implementation of inspection readiness principles, tools, activities, etc.  Review and assess all Clinical Development procedures and standards (including newly created or updated) from compliance perspective, against GxP(s), regulations and industry standard of practice Collaborate with the Training department and Process and Document Management and Improvement department to develop relevant trainings and processes, review the content and provide feed-back and input from compliance perspective Collaborate with Clinical Quality Assurance in audit and inspections, process development, Quality Metrics implementation and oversight within Clinical Development Organization. Show less

Senior Manager Clinical Compliance

• Sep 2018 - Feb 2020

Apply clinical compliance principles to clinical trials- Accountable to evaluate processes, assess compliance risk within clinical trials- Support the management of non-compliances (e.g. deviations, CAPAs, etc.) and ensure enhancement and implementation of inspection readiness principles, tools, activities, etc

Associate Director, Quality assurance Quality Management System

• Oct 2016 - Aug 2018

- CAPA Process oversight and implementation - globally- Deliver training for the QMS (TrackWise) for deviations and CAPAs - Quality Management System implementation and oversight including generating and reporting quality related metrics to high management - Support in conducting of the internal system audits - cross collaborate with all functions for ensuring compliance with the CAPA and deviation process timelines - develop and deliver trainings related to different aspects of the CAPA and deviation process (e.g. root cause analysis etc) Show less

Senior Quality Assurance Manager

• Feb 2015 - Oct 2016

- quality management system implementation and training - implement, oversee and manage the CAPA and deviation process across R&D organization- cross collaborate with all functions for ensuring compliance with the CAPA and deviation process timelines - develop and deliver trainings related to different aspects of the CAPA and deviation process (e.g. root cause analysis etc)

Senior Project Quality Lead

• Nov 2014 - Feb 2015

Project Quality Leader

• May 2013 - Nov 2014

Clinical operation leader

• 2010 - May 2013

• Managing clinical monitoring activities and liaising with project management to ensure that the clinical deliverables are met. • Collaborate with Project Manager and other Functional Leaders across all geographies – involved in the feasibility activities (identify, assess and approve sites), startup activities (EC submission and strategy)• Evaluate and identify resourcing needs and provide performance feed-back• Direct collaboration with the CRA and CMA (in house research assistants) and their line managers• Organize and participate in client, investigator and team meetings• Responsible to review visits reports• Identify and facilitate study training needs, to ensure successful outcome of the project (by monitoring study timelines and patient recruitment)• Assure quality within the study• Prioritize and respond to urgent requests within team• Develop project tools. Show less

Regional Study Manager

• May 2007 - Apr 2010

• Regional study execution in Romania and Bulgaria • Co-monitoring, visit reports reviewing, • Quality check of study documentation • Organize local IMs and serve as primary sponsor for country level information • Coordinated 5 clinical regional projects, leading teams over 10 CRAs. • Specific start-up activities of the studies, site identification, evaluation and qualification. • Clinical guidance and mentoring to the clinical team • Primary point of contact for Global Project Management • Participated and organized team meetings, supported the clinical team in issues resolution.. • Development and performing of study specific training for CRA team • Develop and provide to the Global project management team the study budget and resources requirements for the region. Show less

Site Manager Associate

• May 2007 - Mar 2009

• Preparation of submissions documentation; • Initiating sites; • performing monitoring visits at sites • providing training to the study site staff • Collaborating with other departments for reporting safety information • Collecting Case Report Forms and following up on data queries resolution • Reporting the progress of the study on a regular basis • Performing site close-out visits • Preparing and supporting the sites for audits and inspections. • Preparation of submissions documentation; • Initiating sites; • performing monitoring visits at sites • providing training to the study site staff • Collaborating with other departments for reporting safety information • Collecting Case Report Forms and following up on data queries resolution • Reporting the progress of the study on a regular basis • Performing site close-out visits • Preparing and supporting the sites for audits and inspections.

Pharmacovigilance associate

• 2006 - 2007

Pharmacovigilance associate

• 2006 - 2007

Customer Care Team Leader - Line Manager

• Feb 1998 - Nov 2006

• Coordinating, coaching and evaluating a team of 20 members • Team member development – skills development, personal development, professional development • Ensure the qualitative and quantitative parameters are maintained by the team according to the company requirement • Providing support to the team and to the department to solve difficult issues and customers • Provide highest level service quality to the customers • Involved in the development of integration program for the new employees and development of the customer care questionnaires for company’s surveys • Recruitment activities for the customer care department (1,5 years) Show less

Paging Center assistant

• Jun 1997 - Jul 1998