Vladimir Vasilyev

Experience

• 

  ClinStar

  Aug 2008 - Jun 2009

  CRA I

  • Study site initiation, monitoring;• Preparation and participation in local investigator meetings;• Requesting and monitoring of study material shipments;• Preparing financial contracts and payment documents to investigators and institutions;• Preparation of the Local EC submissions;• Site teams trainings;• TMFs maintenance

• 

  PharmaNet

  Jun 2009 - Jan 2011

  CRA II

  • Study site feasibility assessment, initiation, monitoring, closing;• Preparation and participation in local investigator meetings;• Requesting and monitoring of study material shipments;• Regular participation in teleconferences;• Preparing financial contracts and payment documents to investigators and institutions;• Preparation of the Local EC submissions;• Preparation for the site audits and assisting to the auditor during the audit;• Training Entry Level CRAs. Performing co-monitoring visits with EL CRAs. Assisting Entry level CRAs in after visit reporting;• Site teams trainings;• TMFs maintenance. Show less

• 

  F.Hoffmann - La Roche Ltd.

  Jan 2011 - Mar 2018

  • Accountable for leading and overseeing key business support functions in CCO including Study Start-Up, Vendor Management, Contracts, Resourcing, Logistics, Finance and local business performance and analytics.• Responsible for providing line management to business support function leads (including SSU Line Manager, Resource Manager, Finance Manager, Local Vendor Manager, Contract Manager, Logistic Manager).• Responsible for overseeing – either directly or by overseeing business support staff – contractual, regulatory (when applicable), financial and legal elements of clinical trial operations, including adherence to local Fair Market Value.• Responsible for providing strategic business support and insight to the Country Head to ensure appropriate financial, business and resource planning across the Clinical Operations department.• Accountable for reviewing, analyzing and collecting local metrics to ensure process and systems are in place to drive efficiency and reduce timelines across all business support functions. • Responsible for ensuring strong relationship management of key internal stakeholders, including legal/regulatory/finance/medical/quality/logistics department; ensures strong external stakeholders engagement with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches. • Responsible for oversight of continuous improvement initiatives, within the country/region to proactively identify and share areas for increased efficiency; supports local prioritization of continuous process improvement initiatives derived globally to ensure enhanced efficiency and productivity across business support functions and the broader department. Show less • In collaboration with respective Regional APTS Head, direct the consistency of compliance activities of Pharma Affiliates Clinical Operation that are responsible by providing instructions on Good Clinical Practices, company procedures, regulations and guidelines.• In collaboration with respective Regional APTS Head identify the training needs of Pharma Affiliate Clinical Operation staff in the respective sub region and manage the implementation of training programs.• Ensure the provision of recommendations on audits / inspections for all Clinical Operation staff within the respective sub region/region. • In collaboration with respective Regional APTS Head, ensure process alignment and quality improvement within the respective sub region/region.• Support Pharma Affiliates Clinical Operational staff in resolving quality problems regarding GCP and GCP Roche procedures, or issues escalation.• In collaboration with respective Regional APT Head, develop and support a proactive issue escalation process to the Global Head of Project and Functional Excellence and /or AM Functional Excellence Leader (s) as appropriate.• Support the development, review and implementation of the local procedures (e.g. SOPs) according to regulatory needs and/or based on deficiencies identified during audits/inspections for the respective Pharma Affiliates. Direct the provision of recommendations during the preparation and conduct of audits / inspections in the Pharma Affiliates that are responsible, in addition to contributing with adequate development and timely response plans to audit / inspections, as well as their actions.• Interact appropriately with other relevant global functions to maintain and improve the consistency and communication across the organization• Work as a proactive member of the Regional and Global Processes, Training and Systems team, PDG, Local Medical Affairs, Global Medical Affairs to maintain and improve the consistency and communication across departments. Show less • In collaboration with respective Regional APTS Head, direct the consistency of compliance activities of Pharma Affiliates Clinical Operation that are responsible by providing instructions on Good Clinical Practices, Roche procedures, regulations and guidelines.• In collaboration with respective Regional APTS Head identify the training needs of Pharma Affiliate Clinical Operation staff in the respective sub region and manage the implementation of training programs, to ensure that all of the studies conducted and managed by the Pharma Affiliates are in compliance and conducted in accordance with Roche procedures, regulations and Good Clinical Practices.• Ensure the provision of recommendations on audits / inspections for all Clinical Operation staff within the respective sub region/region • In collaboration with respective Regional APTS Head, ensure process alignment and quality improvement within the respective sub region/region.• Support Pharma Affiliates Clinical Operational staff in resolving quality problems regarding GCP and GCP Roche procedures, or issues escalation. Show less • In collaboration with respective Regional APTS Head, direct the consistency of compliance activities of Pharma Affiliates Clinical Operation that are responsible by providing instructions on Good Clinical Practices, company procedures, regulations and guidelines.• In collaboration with respective Regional APTS Head identify the training needs of Pharma Affiliate Clinical Operation staff in the respective sub region and manage the implementation of training programs.• Ensure the provision of recommendations on audits / inspections for all Clinical Operation staff within the respective sub region/region. • In collaboration with respective Regional APTS Head, ensure process alignment and quality improvement within the respective sub region/region.• Support Pharma Affiliates Clinical Operational staff in resolving quality problems regarding GCP and GCP Roche procedures, or issues escalation.• In collaboration with respective Regional APT Head, develop and support a proactive issue escalation process to the Global Head of Project and Functional Excellence and /or AM Functional Excellence Leader (s) as appropriate.• Support the development, review and implementation of the local procedures (e.g. SOPs) according to regulatory needs and/or based on deficiencies identified during audits/inspections for the respective Pharma Affiliates. Direct the provision of recommendations during the preparation and conduct of audits / inspections in the Pharma Affiliates that are responsible, in addition to contributing with adequate development and timely response plans to audit / inspections, as well as their actions.• Interact appropriately with other relevant global functions to maintain and improve the consistency and communication across the organization• Work as a proactive member of the Regional and Global Processes, Training and Systems team, PDG, Local Medical Affairs, Global Medical Affairs to maintain and improve the consistency and communication across departments. Show less • Timely and accurate guidance to internal staff on the effective implementation of ICH GCP, existing or revised global and local controlled documents, regulatory and local law requirements.• Process and training oversight activities • Contributing as a member of the Global APT Network, sharing best practices and escalating issues to the APT Manager or Regional APT Head.• Supporting the implementation of global, regional and local initiatives.• Recommending and implementing improvements to processes or tools to achieve quality standards and efficiencies. • Ensuring that controlled documents are effectively managed and changes to regulatory requirements or Roche global procedures are embedded into local processes.• Writing and maintaining local standard procedures.• Developing and delivering new training modules• Providing input into training programs to be delivered to internal staff, participating as a regional/local trainer.• Oversight for electronic systems used in the affiliate • Oversight of ICH GCP trainings conducted by external vendors.• Ensuring the affiliate is inspection ready. • Identifying/evaluating risks around clinical trials being conducted by dept from both local and regional level perspective.• Conducting internal audits in line with the agreed internal audit annual plan.• Defining, ranging and documenting risks revealed during internal audit conduct.• Supervising a process of CAPA development by concerned local team/consulting on complicated cases in order to mitigate impact in key areas.• Evaluating and agreeing proposed corrective, preventive or improving actions, checking established success criteria for appropriateness and reviewing implementation process flow if needed. • Ensuring quality risk management (risk identification, assessment, treatment) approach is applied in APT oversight activities with focus on key risks to clinical trial. 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  • Business Support Group Leader (Руководитель группы поддержки бизнеса)

    Jan 2017 - Mar 2018

  • Affiliate Process, Training & Systems Manager (Руководитель группы по процессам,тренингам, системам)

    Jul 2016 - Jan 2017

  • Sub-Regional Affiliate Process, Training & Systems Manager

    Jan 2016 - Jul 2016

  • Affiliate Process, Training & Systems Manager (Руководитель группы по процессам,тренингам,системам)

    Mar 2014 - Jan 2016

  • Affiliate Process&Training Advisor

    Jan 2011 - Mar 2014
• 

  F. Hoffmann - La Roche Ltd

  Mar 2018 - Apr 2022

  Compliance,Process,Training&Systems Manager (Руководитель группы по комплаенс,процессам,тренингам)
• 

  F. Hoffmann-La Roche Ltd

  Apr 2021 - Apr 2022

  Global Process Quality Responsible for Investigational Medicinal Product