Oleksii Bugaienko Email & Phone Number

Ukraine

Collaboration with project teams and with the Study Start-Up Manager to perform key study start-up tasks: study feasibility, site identification and qualification, collection of essential documents, facilitation of site contract and budget negotiations, and other study start up activities. Also responsible for facilitating the collection of essential regulatory documents from sites and preparation or review of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws, guidelines and ethical standards within specific timelines and quality standards. Working with eTMF and Sharefolders, documents review, check and uploading.

Киев

- Work with clinical trials documentation and databases (TMF and ISF documents preparation, distribution, gathering and uploading);- Communication with sites (preparation and collection of essential documents, payments, regulatory);- Tracking and reporting of study progress / study status, at study and at site level (including regulatory);- Clinical Trials Agreements and amendments preparation, negotiation and finalization;- Payments to investigators and institutions handling (invoices and acts of acc. preparation, controlling and tracking of payments, payments issues resolving, reporting);- Shipments and tracking of study documentation and study material;- Translation of documents handling and communication with translation agency;- Office administrative work (office stationary and equipment ordering, work with vendors);- Start-Up work (Pre-study essential documents preparation, collection, correction and finalization, work with CTAs, trackers preparation);- Regulatory work (substantial amendments submissions to RA and LEC's preparation and providing, review and correction of submission documents, providing of reports and notifications submissions to RA, RA contract and payments issues resolving, RA and LECs approvals and acknowledgments receiving etc.).

Kiyv, Ukraine

- Work with clinical trial documentation (CRA assistance, ISF preparation, documents archiving, trackers preparation);- Assistance in reporting of study progress / study status, at study and at site level;- Work with contracts and additional agreements;- Finance work (invoices and acts of acc. preparation, controlling of payments, work with banks);- Shipment and tracking of study documentation and study material;- Translation of documents handling and communication witrh translation agency;- Office administrative work;- Regulatory work (Submission of documents to CA and LEC's preparation, invoices and approvals receiving);- Quality assurance work (work with QM database, QM trackers preparation, training records preparation, standard operational procedures tracking).

Kyiv, Ukraine

State Joint Stock Company Artem is a big trader of military technique on foreign market. Foreign Economic Department is responsible for negotiations with clients, contract work, shipment and logistics work, work with customs (shipment documents preparation, receiving approvals from state organizations), finance controlling, manufacture controlling. Main responsibilities:- Selling of military equipment (negotiation with clients, work with contracts and supporting documentation);- Finance work (invoices and trackers preparation);- Terms of manufacturing and payments control (working with finance and manufacture department);- Shipment of military equipment (shipment documentation preparation, obtaining of certificates and approvals from state organizations, communication with customs brokers);- Shipments and manufacture trackers preparation;- Translation of documents handling, communication with translation agency;- Controlling of small aviation equipment trade.

Kyiv, Ukraine

State Joint Stock Company Artem is a big trader of military technique on foreign market. Foreign Economic Department is responsible for negotiations with clients, contract work, shipment and logistics work, work with customs (shipment documents preparation, receiving approvals from state organizations), finance controlling, manufacture controlling. Main responsibilities:- Selling of small aviation equipment (work with contracts and supporting documentation);- Terms of manufacturing and payments control (working with finance and manufacture department);- Shipment of military equipment (shipment documentation preparation, communication with customs brokers);- Translation of documents handling, communication with translation agency;

Магистр, Менеджер Вэд

Master'S Degree, Managment Of Foreign Economic Activity, Master'S Degree With Honors