Anna Kamińska

Experience

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  Elite Cafe

  Sept 2000 - Apr 2004

  Administrative Specialist

  - Controlling and recording of all the documents associated with sales - Bookkeeping- Preparing financial reports for the company Board

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  Symphar Sp.z o.o.

  Jun 2004 - Oct 2007

  Hospital Business Medical Representative / Trainer, Surgical Products

  - Managing local public tender- Managing collaboration with KOLs- Organizing conferences and meetings- Providing trainings for doctors and nurses- Coaching new Medical Representatives

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  Janssen-Cilag Polska Sp. z o.o.

  Nov 2007 - Nov 2008

  Medical Representative, Gynecology

  - Managing marketing and educational activities- Managing collaboration with KOLs- Organizing conferences and meetings

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  Medicare Partners

  Dec 2008 - May 2009

  Entrepreneur, Medical Tourism Coordination

  - Supporting logistics and networking for medical tourism

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  MSD

  Jun 2009 - May 2010

  Medical Representative, Cardiology

  - Managing marketing and educational activities- Managing collaboration with KOLs- Organizing conferences and meetings

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  3M

  Jun 2010 - Jan 2017

  Key Account Specialist / Medical Representative, Dental Products

  - Introducing new brands and solution to the market- Managing collaboration with local KOLs and medical societes- Organizing conferences and meetings- Developing commercial strategy for assigned territory- Providing trainings for doctors and key customer's employees- Managing key account business within territory- Tradeshow events booth duties- Coaching and introducing new Medical Representatives

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  Dental Clinic

  Sept 2017 - Jun 2019

  Dental Hygiene Associate

  - Assisting in dental treatment procedures- Dental hygiene coaching for patients

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  Medical Research Institute ALL-MED

  Nov 2019 - Jan 2020

  Clinical Research Site Coordinator Internship

  - Clinical study feasibility assessment- Clinical study site operations set-up and planning- Study database and clinical study documentation- Communication with CRO/Study Sponsor- Pre-screening activities (identification of potential study subjects)

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  Wroclaw Medical University

  Oct 2020 - Dec 2021

  Regulatory & Start Up Specialist / Project Leader

  - Development and processing of Confidentiality Agreements and service contracts for/with subcontractors (e.g. CROs), Tripartite Agreements, and contracts for members of the research teams- Preliminary qualification of new projects, and project feasibility assessments- Oversight for preparation of documentation necessary to start and conduct of clinical studies (informed consent form, instructions, information for the study participants, etc.)- Coordination of Start-Up Phase activities- Financial project monitoring- Oversight for monitoring and pharmacovigilance services provided by CROs- Collaboration with the National Project Coordinator in solving issues and driving key decisions- Monitoring the implementation and realization of project indicators / milestones- Oversight for research sites teams set-up- Monitoring/review of data in the eCRFs- Preparing and submitting EC and RA applications, ongoing submissions and amendments under CTD- Collection and filing of documents to TMF- Cooperation with the Legal, Finance, Human Resources and Tenders Departments- Management of subcontractors and suppliers selection process- Identification, selection and sourcing of supplies (e.g. medical devices) for clinical studies Show less

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  Syneos Health

  Jan 2022 - Jul 2022

  Regulatory & Start Up Specialist 1

  - Preparing and submitting EC and RA applications, ongoing submissions and amendments under CTD- Quality control of start-up TMF documents (Regulatory Green Light process) - ICFs country customizing, according to country requirements- Point of contact for Sponsor in terms of tracking progress, identifying risk areas and reporting.

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  IQVIA

  Apr 2023 - now

  Regulatory & Start Up Specialist 2

  Additional activities beyond the Start-up and Regulatory position:- SME role for Sponsor (Site Activation Manager and Regional Clinical Trial Manager support)- Recruitment process (Line Manager support - reviewing CVs, conducting an interview)- Audit activities (both - preparation and active participation in the audit interview).- Global and Polish QC submissions - Mentoring activities (CTA support)- Contract and Budget Negotiation activities (Amendments)- Cooperation with Veeva Consultants on the development of Country Intelligence of OMP (One Medicine Platform) using Veeva technology with applications such as Study Startup, eTMF, CTMS and others.Start up & Regulatory activities:- Providing local start-up activities and delivering them within agreed timelines- Responsibility for preparation of Part II documents for submissions under EU CTR- Substantial Amendments and transitions for trials in old mode CTD- Managing IRB/RA queries in collaboration with Site Activation Manager and Sponsor’s Study Team- Attending SAM and Sponsor’s Meetings and providing local expertise for start up activities - Tracking, filling, compliance and reporting of current submissions status- Requesting and managing translations of documents needed for submission- ICF country customization - Direct Line of communication with EC / RA and Sites - Collecting and quality check of Site essential documents Show less