Experience

Pratia

• Poland
• Research
• 100 - 200 Employee

• Head, Global Contract Manager

  • Mar 2022 - Present

  Pratia, Head, Global Contracting Strategy Manager • Developing template of master service agreements, work orders, stand alone CTAs, CDAs • Collaborating with sponsors, CROs, stakeholders and country team members • Providing legal support, operational and financial contracting support • Assessing and reviewing contracts and budgets



Umowa zlecenie/freelancing

• Freelance clinical contract manager

  • Jan 2021 - Present

  Clinical Legal owner https://clinicallegal.pl/en Freelance contract manager/contract negotiator – owner of Clinical Legal – entity supporting CROs and pharmaceutical companies • negotiating budgets and clinical contracts with sites and investigators on behalf of • CROs and Sponsors supporting mainly European region • preparing templates and negotiating contracts with vendors and study team • members • administering all contract management processes, including coordination… Show more Clinical Legal owner https://clinicallegal.pl/en Freelance contract manager/contract negotiator – owner of Clinical Legal – entity supporting CROs and pharmaceutical companies • negotiating budgets and clinical contracts with sites and investigators on behalf of • CROs and Sponsors supporting mainly European region • preparing templates and negotiating contracts with vendors and study team • members • administering all contract management processes, including coordination with • relevant protocol, informed consent, institution, investigator, vendor, consultant, • and customer agreement documents at a project level. • preparing amended documents as necessary, preparing contract management • documentation for projects, and streamlining the contract/proposal or internal processes • representing sites and investigators during contract negotiations with sponsors Show less



IQVIA

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

• Site Contract Manger in IQVIA

  • Sep 2020 - Feb 2022

  IQVIA – Investigator Site Contracts Manager • Developing of complex investigator grant estimates, contracting strategies and proposal text to support the proposal development process. • Developing contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy. • Ensuring collaboration, including… Show more IQVIA – Investigator Site Contracts Manager • Developing of complex investigator grant estimates, contracting strategies and proposal text to support the proposal development process. • Developing contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy. • Ensuring collaboration, including communication with sponsors, stakeholders and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan. • Providing specialist legal, operational and financial contracting support to facilitate efficient business development and initiation and maintenance of complex clinical trials, whilst ensuring compliance with regulatory requirements and local laws. • Assessing and review the contracting landscape and contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required. • Ensuring overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required. • Mentoring and coaching colleagues as required and provide technical guidance both within and outside the project. • Delivering presentations to clients and professional bodies as required. • Ensuring accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans. • Taking a lead role in developing long standing relationships with customers; may serve as a liaison for non-specific projects for top customers Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Site Contract Specialist

  • Apr 2019 - Sep 2020

  Kraków, woj. małopolskie, Polska Working in a SSU department • lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. • Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. • Negotiates budget and contract with site and via Site Contracts Service… Show more Working in a SSU department • lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. • Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. • Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. • Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented. • Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. • Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions. • Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms. • Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog. • Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Establishes strong working relationships with SSU lead, customer and internal project teams. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.

• Senior Site Contract Specialist - Contract Set up Lead/Study Contract Lead

  • Oct 2019 - Jul 2020

  Kraków, woj. małopolskie, Polska Working as as PSUL in Site Contract Service Center- Project Set up lead responsible for drafting a contract • Actively participates in higher level discussions about overall company goals, functional objectives in the BU, and specific project aims. • Act as Lead on assigned projects and manage the contract and budget development process • Act as primary customer interface on large, complex contracts, responsible for maintaining and developing customer relationships • Subject… Show more Working as as PSUL in Site Contract Service Center- Project Set up lead responsible for drafting a contract • Actively participates in higher level discussions about overall company goals, functional objectives in the BU, and specific project aims. • Act as Lead on assigned projects and manage the contract and budget development process • Act as primary customer interface on large, complex contracts, responsible for maintaining and developing customer relationships • Subject matter expert equipped to help resolve global site contracting issues. Escalation point within the Company for internal customers to seek assistance. • Proposes contracting solutions to issues that may arise during a project or contract life cycle, to enhance negotiation strategy and ensure deliverables are met. • Works closely with Legal and other internal stakeholders to draft, negotiate with Sponsor and harmonize site contract templates, site contract language, fallback and/or investigator budgets templates and parameters, within Company processes • Establishes site contract project strategies around language and/or budget negotiation parameters to reflect sponsor's master service agreement terms and required processes. • Identifies possible contract or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance. • Ensures site contract templates are drafted taking into consideration key operational aspects indicated in the relevant operational documents (e.g. protocol, pre-study visit report, etc.) • Establishes strong working relationships and collaboration with Sponsor to ensure site contract and budget templates fit into the global strategy set for the program. • Creates and maintains document status reports and updates department team members on a regular basis;



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Site Contract Specialist II- Contract Negotiator

  • Nov 2016 - Mar 2019

  Kraków, woj. małopolskie, Polska Work in Clinical research company as contract negotiator: -preparing templates and negotiating contracts with vendors, sites, investigators in Poland, Sweden, Netherlands, Norway, Denmark - preparing budget and negotiating financial parameters with Client - cooperate with external vendor and negotiate financial budget - GDPR implementation, taking care of personal data protection process - Administers all contract management processes, including coordination with relevant… Show more Work in Clinical research company as contract negotiator: -preparing templates and negotiating contracts with vendors, sites, investigators in Poland, Sweden, Netherlands, Norway, Denmark - preparing budget and negotiating financial parameters with Client - cooperate with external vendor and negotiate financial budget - GDPR implementation, taking care of personal data protection process - Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. - Anticipates risk/benefit issues, assists with remedial action plans, and troubleshoots to resolve any concerns. - Assists Contract Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues. - Assists in generating amended documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions. - Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions. - Facilitates contract management functions with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues. - Facilitates the execution of contracts by company signatories. - Maintains contract templates and site specific files and databases. - Assists with negotiation and preparation of contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented. - Serves as communication liaison between site contracts staff and internal and external customers. Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Site Contract Leader - Contract Negotiator

  • Dec 2015 - Oct 2016

  Working in CRO company as Local Contract Negotiator, main duties: - Prepare and negotiate contract with sites the respective contract in accordance with the contract strategy agreed with the Sponsor, contract turnaround timelines, - prepare budget negotiation parameters. negotiate financial parameters -Work within the defined “fallback” / approval parameters to manage / resolve significant contract changes requested by the site -Escalate changes that fall outside the… Show more Working in CRO company as Local Contract Negotiator, main duties: - Prepare and negotiate contract with sites the respective contract in accordance with the contract strategy agreed with the Sponsor, contract turnaround timelines, - prepare budget negotiation parameters. negotiate financial 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 PL/COL informed about contract progress and any issues/challenges during the contract negotiation. -Maintain contract negotiation status accurately tracked in CTMS -Collect contract signatures -File fully executed contract -Early recognition of areas of potential problems and formulate contingency plans -Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, andSOPs and study specific procedures -Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics,travel expense claims) Show less



HSBC

• United Kingdom
• Financial Services
• 700 & Above Employee

• KYC Standards Policy Implementation Analyst w HSBC

  • May 2015 - Nov 2015

  Kraków, woj. małopolskie, Polska Supporting regional Policy Heads in implementation of global KYC Standards across HSBC -leading discussion and proposing resolution to assigned Policy-related issues - focus on effective operational execution and be responsible of the service provided by the team of personal data operation - support the team in dealing with inbound contacts from individuals, requesting management of their personal data that is processed by company -in-depth analysis of issues -preparing… Show more Supporting regional Policy Heads in implementation of global KYC Standards across HSBC -leading discussion and proposing resolution to assigned Policy-related issues - focus on effective operational execution and be responsible of the service provided by the team of personal data operation - support the team in dealing with inbound contacts from individuals, requesting management of their personal data that is processed by company -in-depth analysis of issues -preparing template guidance instructions, workarounds,NGT change requests, decision trees, document updates eg. GSG or LoB etc., preparing PPT slides -PSD items maintenance (updating items, changing status etc) -active participation in calls with SMEs, FCC, working groups, model office calls etc -administrative tasks eg. setting up webex meetings, meeting minutes etc -proactive identification of Policy gaps/inconsistencies and areas for improvement -Policy sharepoint administration (adding/removing links, documents, information) -anything assigned by Policy Heads Show less



prawnieskuteczni.pl

• Twórca serwisu oraz prawnik w prawnieskuteczni.pl/Owner of prawnieskuteczni.pl

  • Mar 2014 - Nov 2015

  Main responsibilities - advising clients on each stage of e-commerce operations - preparing the necessary documentation connected with Internet domains and trademarks - elaborating regulations and personal data processing models and finally supporting promotion and advertising - creating the privacy policies and terms and conditions for online shops and mobile apps - drafting NDA/ CDA agreement - auditing performance of personal data protection - implementing new… Show more Main responsibilities - advising clients on each stage of e-commerce operations - preparing the necessary documentation connected with Internet domains and trademarks - elaborating regulations and personal data processing models and finally supporting promotion and advertising - creating the privacy policies and terms and conditions for online shops and mobile apps - drafting NDA/ CDA agreement - auditing performance of personal data protection - implementing new solution of personal data protection Serwis internetowy www.prawnieskuteczni.pl zajmuje się świadczeniem usług prawnych z zakresu prawa nowych technologii oraz prawa internetu. Serwis zajmuje się: Regulaminami + Regulaminy dla sklepów i serwisów + Audyt i modyfikacja regulaminów + Zmiany w prawie konsumenckim Ochroną danych osobowych + Opracowanie dokumentów i doradztwo prawne w zakresie ochrony danych osobowych IT i Prawem autorskim + Umowy z zakresu prawa nowych technologii i prawa autorskiego + Obsługa prawna przedsiębiorcy Publikacje na portalu www.mamstartup.pl  Dane osobowe w chmurze a obowiązki przedsiębiorcy http://mamstartup.pl/poradnik/5708/dane-osobowe-w-chmurze-a-obowiazki przedsiębiorcy  Crowdfunding udziałowy http://mamstartup.pl/poradnik/6058/warunki-prawne-ktore-musisz-spelnic-organizujac-crowdfunding-udzialowy  Administrator Bezpieczeństwa Informacji http://mamstartup.pl/poradnik/6095/nie-bedziesz-musial-zatrudniac-administratora-bezpieczenstwa-informacji  Wszystko co powinieneś wiedzieć o vestingu http://mamstartup.pl/poradnik/6412/wszystko-co-powinienes-wiedziec-o-vestingu Show less



HSBC Service Deliver Sp. z o.o.

• KYC Junior Analyst

  • Mar 2014 - May 2015

  Zabierzów * Processioning periodic KYC due diligence reviews on the required quality and detail on a timely basis, * Performing research via internal and external sources, gathering and analy sing the documentation in accordance with regulatory CIP/KYC requirements. * Analysing the AML risk associated with the client: monitoring and capturing various risk factors in context of AML/CTF Risk * Indexing, processing and uploading documentation into internal systems * Analysing publicy… Show more * Processioning periodic KYC due diligence reviews on the required quality and detail on a timely basis, * Performing research via internal and external sources, gathering and analy sing the documentation in accordance with regulatory CIP/KYC requirements. * Analysing the AML risk associated with the client: monitoring and capturing various risk factors in context of AML/CTF Risk * Indexing, processing and uploading documentation into internal systems * Analysing publicy available information in the context of risk related to money laundering, reputational risk, regulatory allegations and other risk factors which need to be identified in line with US regulatory requirements. Show less



Ornatowski Roszczynialski Kancelaria Radców Prawnych

• Prawnik- Lawyer

  • Jan 2013 - Mar 2014

  -Arranging meetings & assisting with the drafting & amending of legal documents. -Performing substantive legal work, conducts research & provides legal support. -Creating court/matter bundles, filing & issuing documents at court. -Performing legal research for solicitors and senior managers. -Acting as a liaison with outside law firms. - Preparing documents including contracts, agreements and transcripts. - Prepare legal documents i.e. contracts, company policies & trademark… Show more -Arranging meetings & assisting with the drafting & amending of legal documents. -Performing substantive legal work, conducts research & provides legal support. -Creating court/matter bundles, filing & issuing documents at court. -Performing legal research for solicitors and senior managers. -Acting as a liaison with outside law firms. - Preparing documents including contracts, agreements and transcripts. - Prepare legal documents i.e. contracts, company policies & trademark applications. - Responsible for coordination and administration of contracts. - Taking part in court hearings, trial, arbitration & mediations. Show less



Kancelaria Chajec, Don-Siemion & Żyto

• Asystent Radcy Prawnego

  • Sep 2012 - Dec 2012



Kancelaria Radcy Prawnego Ewa Wyssenhoff

• Asystent Radcy Prawnego

  • Mar 2012 - Sep 2012



Kancelaria SGB Sobczak, Gardulska, Bacewicz - adwokaci i doradca podatkowy sp.p.

• Stażysta

  • Oct 2010 - Apr 2011



Uniwersytecka Poradnia Prawna UJ – Sekcja Prawa Cywilnego

• Student

  • Jul 2009 - Jul 2010



Polskie Szkoły Internetowe Libratus

• Staż

  • Jul 2009 - Sep 2009