Anna Bąkowska

Experience

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  Law Firm Krzysztof Wieczorek

  Nov 2010 - Feb 2011

  Trainee
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  KCR S.A.

  Jun 2013 - Jul 2016

  • Creating templates of site contracts and amendments• Harmonizing site contract to reflect sponsor's master service agreement terms• Negotiating and finalizing sites contracts• Creating, reviewing and negotiating confidentiality agreements• Identifying project and individual site contract related problems and working with internal and external team members to provide and implement solutions• Ensuring that site contracts are in compliance with sponsor and company requirements Show less • Created, reviewed and negotiated contracts with sponsor, vendors, external consultants and companies within KCR Group• Creating templates of site contracts and amendments• Harmonizing site contract to reflect sponsor's master service agreement terms• Negotiating and finalizing sites contracts• Created, reviewed and negotiated confidentiality agreements• Prepared applications to National Court Register and provided corporate support to the company• Created and improved legal processes other legal documents according to the company’s needs• Provided on-going legal suport Show less

  • Site Contracts Specialist

    Apr 2015 - Jul 2016

  • Legal Specialist

    Oct 2014 - Apr 2015

  • Legal Assistant

    Jun 2013 - Oct 2014
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  Parexel

  Jul 2016 - Jul 2023

  •Act as functional Leader on projects and develop study specific contract and budget strategy•Support site confidential disclosure agreements negotiations•Agree and negotiate study specific generic and/or country contract templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor•Gather relevant study information from study team•Discuss and finalize specific country contract templates with input from Sponsor, study team•Prepare and negotiate with sites the respective contracts in accordance with the strategy agreed with the Sponsor, contract turnaround timelines, CTMS tracking requirements and budget negotiation parameters•Work within the defined “fallback” / approval parameters to manage / resolve significant contract changes requested by the site•Escalate changes that fall outside the documented “fall-back” parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied•Proactively keep Study Team informed about contract progress and any issues/challenges during the contract negotiation•Early recognition of areas of potential problems and formulate contingency plans•Participate in client, investigator and team meetings•Maintain and assure quality of work generated•Prioritize effectively and respond to urgent requests within team or sponsor lead•Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and company SOPs and study specific procedures Show less •Act as functional Leader on projects and develop study specific contract and budget strategy•Support site confidential disclosure agreements negotiations•Agree and negotiate study specific generic and/or country contract templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor•Gather relevant study information from study team•Discuss and finalize specific country contract templates with input from Sponsor, study team•Prepare and negotiate with sites the respective contracts in accordance with the strategy agreed with the Sponsor, contract turnaround timelines, CTMS tracking requirements and budget negotiation parameters•Work within the defined “fallback” / approval parameters to manage / resolve significant contract changes requested by the site•Escalate changes that fall outside the documented “fall-back” parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied•Proactively keep Study Team informed about contract progress and any issues/challenges during the contract negotiation•Early recognition of areas of potential problems and formulate contingency plans•Participate in client, investigator and team meetings•Maintain and assure quality of work generated•Prioritize effectively and respond to urgent requests within team or sponsor lead•Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and company SOPs and study specific procedures Show less •Act as functional Leader on projects and develop study specific contract and budget strategy•Support site confidential disclosure agreements negotiations•Agree and negotiate study specific generic and/or country contract templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor•Gather relevant study information from study team•Discuss and finalize specific country contract templates with input from Sponsor, study team•Prepare and negotiate with sites the respective contracts in accordance with the strategy agreed with the Sponsor, contract turnaround timelines, CTMS tracking requirements and budget negotiation parameters•Work within the defined “fallback” / approval parameters to manage / resolve significant contract changes requested by the site•Escalate changes that fall outside the documented “fall-back” parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied•Proactively keep Study Team informed about contract progress and any issues/challenges during the contract negotiation•Early recognition of areas of potential problems and formulate contingency plans•Participate in client, investigator and team meetings•Maintain and assure quality of work generated•Prioritize effectively and respond to urgent requests within team or sponsor lead•Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and company SOPs and study specific procedures•Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims) Show less

  • Principal Site Contract Leader

    Apr 2023 - Jul 2023

  • Senior Site Contract Leader

    Jan 2020 - Apr 2023

  • Site Contract Leader

    Jul 2016 - Jan 2020
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  ICON Strategic Solutions

  Jun 2023 - now

  Senior Site Contract Manager - Argenx

  • Responsible for managing the coordination of site contract and budget activities • Develop and implement a robust, scalable and efficient country and site contracting and budgeting process and oversight across all trials• Responsible to establish (together with clinical study managers and CROs), manage and drive country and site startup plans according to required timelines, including establishing country and site prioritization plans • Track site startup progress and contract cycle times (e.g. using CRO systems) and ensure acceleration opportunities are identified and taken• Review site contract templates and drafts in negotiation, in close consultation with argenx legal group• Review and benchmark site budget templates with CROs• Where necessary, contact sites directly to accelerate agreements by removing bottlenecks and resolving stalemate situations relating to budget items• Ensure FMV compliance, in liaison with legal compliance function, for site budgets beyond benchmarking parameters• Create and maintain repository for site budget and contract knowledge to allow recycling of contracts and confirmation of effective and acceptable budget thresholds consistent across studies and sites • Work closely with the clinical study manager(s) responsible for assigned trials, the legal and finance groups as well as the CROs assigned to the studies Show less