Experience

Clinscience

• Poland
• Research Services
• 100 - 200 Employee

• Head of Clinical Operations Department

  • Nov 2020 - Present

  Responsible for:- leading Clinical Operations Department having in its scope Project Management, Project Support & Clinical Operations teams;- supporting Business Development Department in discussions with Clients, as well as for assessing the feasibility of budgets and projects' realization strategies (RFPs);- vendors qualification, selection and oversight.

• Project Manager

  • Jan 2020 - Oct 2020

  Responsible for:- planning, initiation, conduct and closure of international phase I-IV clinical trials;- leading study teams;- contracting and supervising external vendors;- CRAs mentoring and training; - performing accompanied MVs;- reviewing/ approving MVs reports; - development of the recruitment strategies and contingency plans; - study sites preparation for the audit; - organizing and leading the Investigators Meeting;- processes of study specific documents preparation (e.g. study plans, protocols, ICFs, etc.);- study budget maintaining (including Work Orders negotiations);- managing process of the site contracts preparation.



Johnson & Johnson

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

• Clinical Study Manager/ Clinical Operations Team Lead

  • May 2019 - Dec 2019

  Clinical Study Manager: responsibilities as indicated belowClinical Operations Team Lead:Line Manager for a group of Associate Clinical Study Managers/ Clinical Study Managers, responsible for supporting all aspects of line management including, but not limited to:- performance management,- development plans co-creation and maintenance,- training, guidance on company policies, mentoring,- ensuring a strong team approach as well as effective, cross-sector collaboration and communication.

• Clinical Study Manager

  • Sep 2018 - Apr 2019

  Main responsibilities:• leading and managing staff and study teams;• managing and providing guidance to all functional areas involved in the study conduct;• managing processes of preparation and review all study-specific documents including but not limited to protocols, ICFs, CRFs, project plans, CSRs and reports for registration on public registries;• managing process of preparation the Clinical Trial Agreements/site contracts, Purchase Orders, Transfer of Obligations & Compliance actions;• participating in the process of service providers evaluation and selection;• ensuring Sponsor's oversight by overseeing the progress of studies and performance of service providers on a continual basis;• ensuring that clinical trials are conducted in compliance with the study protocol and all contractual agreements.



KCR

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Proposal Manager

  • Dec 2017 - Jun 2018

  Responsible for:• proposal and budget preparation based on RFP (Request for Proposal) assumptions;• initial qualification and business analysis of the Client’s situation;• budget negotiations with Sponsor;• cooperation with the Company's business partners (maintaining business relations, updating pipeline reports, collecting applications and negotiating financial terms);• overseeing effectiveness of legal processes (contracts, letters of intent, etc.) until the project is passed for implementation to the operational department;• developing and supervising proposal budget template;• providing data to the Company pricing policy;• preparation the financial analyzes of completed projects;• participation in regular meetings with the President of the Board;• preparation of reports: profit / loss ratio;• providing data for annual budgets;• verification of market trends for clinical trials, key competitors identification



Premier Research

• United States
• Biotechnology Research
• 700 & Above Employee

• Line Manager (Project Support department)

  • Sep 2016 - Nov 2017

  Line Manager of 18 Project and Senior Project Specialists. Since May until November 2017 fully responsible for EU region.Responsible for: • supporting all aspects of line management including, but not limited to, performance management (quality, quantity and timeliness of work performed), and guidance on corporate policy, training and support;• ensuring staff are working within budgeted hours on the study level and meeting utilization requirements at the company level;• promoting a strong team approach to ensure project alignment through active collaboration and communication with project management and other departments;• providing training by implementing effective orientation, mentoring, and career development programs for staff;• promoting communication with direct reports (through bi-weekly one on one meetings, regularly scheduled project support update meetings, email, phone etc.) and project managers, project directors, and clinical managers on projects to which they are assigned;• providing knowledgeable, demonstrated leadership to the team;• reviewing potential staff CVs and conducting of the interview process;• providing a working environment conducive to employee retention through ensuring work/life balance, ability for career advancement, and creating a respectful work environment;• participating in the development, training and updating of clinical Standard Operating Procedures, Local Working Guidelines and departmental policies;• participating in the mentoring and training of less experienced members of staff in other departments in addition to the Project Support Team;• monitoring and managing internal/external stakeholder satisfaction.

• Senior Project Specialist/ Associate Project Manager

  • Jan 2015 - Aug 2016

  From January to August 2016: Associate Project Manager responsible for two ph3 studies.As SPS:• developing, maintaining, and updating the project plans, and tracking tools for project documents/ deliverables and monthly progress reports, customizing project templates • coordination the start-up activities• developing and maintaining the study training list• identifying resources as per the project Scope of Work • providing competent support for efficient project team meetings, both internal and external, including scheduling and leading; preparation and distribution of meeting minutes; maintenance of action item logs including managing direct follow-up on action items to ensure appropriate resolution• coordination the creation and dissemination of study newsletters • being a backup for the PM and be responsible for communications both internally and externally in their absence• developing, maintaining, updating, and disseminating study timelines in accordance with the study proposal, as well as feedback from FLs and the sponsor• (under limited direction of PM) developing, maintaining, and updating financial tools to track project budgets by: - ensuring project tasks codes are appropriately established and shared with the project team- coordination regular meeting with PFA to accurately project revenue for assigned study - identifying, tracking, and forecasting out of scope services, and preparing/ maintaining Change Orders- managing the timely approval and tracking of pass-through invoice in accordance with the executed contracts- actively alerting PFA when contractual timelines are met to trigger agreed milestone payments- coordinating vendor management, including tracking and managing supplies, invoices and budget• initiating eTMF development, ensuring that the TMF is accurate, complete, and audit ready• identifying and tracking applicable SOP and SOP deviations and initiates CAPA plans



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• In-house CRA

  • Oct 2013 - Dec 2014

  Responsible for:• remote monitoring visits (SQV,SIB,IMV,EOS);• co- monitoring visits with CRAs;• co-organization and attending the IMs;• conducting general site contacts in accordance with the study specific Monitoring Plan• generating contact reports in accordance with departmental timelines and/or sponsor timelines;• preparation sites and CRAs for on-site visits;• compilation Site Regulatory Package for review and approval;• submitting and follow up with site on CSA including budget, Anti-Bribery Law Survey, and site specific ICF;• collecting site specific documents for EC, and RA;• supporting site with access to relevant study systems and ensuring sites are compliant with project specific training requirements;• ascertaining and recommending appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training;• collaborating with Clinical Trial Specialist and CRA on site issues/actions and providing recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff;• performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and ISIS) and ensuring timely and high-quality data entry compliance from sites;• re-training site staff on study specific tasks/procedures;• identifying and evaluating potential data quality issues; and determining and implementing appropriate follow-up response;• ensuring timely resolution and closure of all site issues (including Central File QC findings);• collecting updated/amended regulatory documents in collaboration with CRA and CTS;• updating all appropriate CTMSs as indicated per function on an ongoing basis and submits all relevant documents to central files as per Central File Maintenance Plan;

• Clinical Trial Specialist II

  • Nov 2012 - Oct 2013

  Responsible for:• action site selection strategy;• refining project-specific site selection strategy at a country level;• identifying new potential Investigators and enters/updates clean information into the tracking systems;• ensuring feasibility, review and approval of site identification list coming from FCI;• conducting country specific feasibility and/or site pre- qualification and/or remote qualification visits and/or site selection activities (except for on-site qualification visits, which will be done by CRAs);• creating country specific / site specific Informed Consent Form (ICF);• reviewing and approving country specific ICFs;• preparing and negotiating clinical site agreement at a site level;• preparing and submitting IRB/EC application until final approval received (initial submission /Amendments);• customizing a Site Regulatory Package Guidelines;• collecting and compiling regulatory documents in collaborations with the CRA;• conducting (on a regular basis) outbound and receives inbound calls to:- review recruitment plan,- address/resolve issues pending from qualification visit,- address protocol questions,- check on site staff assignment,- request outstanding documents.• follow-up on appropriate site related questions;• reviewing/ approving Site Regulatory Package (and updating tracking system once regulatory documents are approved);• adapting drug label for country requirements;• organizing translations per country/ regulatory/ client requirements;• creating the country specific template of contracts and negotiations;• submitting safety updates to IEC;• preparing and submitting RA documentation (and for follow-up until final approval received)- Initial Submission/ Amendments;• assisting with QC/audit of central files and liaising with Research Regulatory Compliance (RRC) personnel as required

• Clinical Trial Specialist I

  • Jul 2011 - Nov 2012

  As above.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trial Administrator

  • Sep 2009 - Jun 2011

  Responsible for:• updating Medical Department procedures;• feasibility supervision;• creation and negotiation of site contracts;• preparation and submission of RA/ IEC documentation and follow-up until final approval received (Initial Submission/ Amendments);• planning/ maintaining/ performing the Investigator and Site Payments;• organizing and attending the Investigator’s Meetings (local and abroad);• conducting sites co- monitoring visits with CRAs, and supporting CRAs in solving diagnosed issues;• assuring study drug is available at sites;• supporting sites in answering queries, and eCRF related issues;• managing study related databases (CTMS, IVRS, TMF, eCRF);• archiving clinical study documentation (locally and centrally).

• Clinical Research Assistant

  • Jan 2007 - Sep 2009