Summary
Overview
Work History
Education
Skills
Certificates And Trainings
Personal Information
Consent
Timeline
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Emilia Paulina Dobko

Emilia Paulina Dobko

Study Manager
Białystok

Summary

Experienced Study Manager with valuable on-site experience in project management within the clinical trials, skilled in collaborating across diverse teams and functions to deliver robust support. With a proven track record of facilitating effective communication and coordination, I excel in ensuring seamless operations and achieving project objectives. Passionate about optimizing study processes and leveraging cross-functional expertise to drive successful outcomes.

Overview

7
7
years of professional experience
2
2
years of post-secondary education
2
2
Languages

Work History

Study Manager

GSK, Global Clinical Development (GCD) Poland
06.2023 - Current
  • Collaboration with Supply Chain and acting as the first point of contact for matters related to IP and drug supply, monitoring and managing various aspects of the supply chain process to ensure efficiency, compliance, and effectiveness
  • Collaboration with SDLs within the framework of EU CTR, coordinating cooperation among stakeholders to ensure comprehensive handling of tasks related to EU CTR
  • Vendor management activities (Clario eCOA, Clario ECG, Illingworth Home Health Nursing) including participation in weekly meetings, overview on the translation process, point of contact for Vendor Project Managers, acting as back up for SDL
  • Clinical Safety Reports Distribution SME (in training) – part of a Process Simplification Team to provide a clear end-to-end clinical process with defined roles and responsibilities to ensure on time distribution of investigational product safety information to sites/CRO, ECs and RAs
  • Peparation and update of study documents and study plans (Monitoring Plan, Site Training Plan, Rater Training Plan, PDNC Plan, Sample Analysis Plan) and technical support during central trial documents creation.

Study Delivery Specialist

GSK, Global Clinical Development (GCD) Poland
11.2021 - 05.2023
  • Collaboration with the SDL to provide end to end operational and administrative support for study delivery activities (CST meeting preparation, meeting minutes, Team Lists and study documentation trackers maintenance for e.g
  • Issues and decisions log)
  • TMF management and TMF-A oversight including EDL management, Study metrics and completeness checks, CRO Spot checks - contributing to inspection readiness
  • Vendor management activities (Clario eCOA, Clario ECG, Illingworth Home Health Nursing) including participation in weekly meetings, overview on the translation process, point of contact for Vendor Project Managers, acting as back up for SDL
  • TCS oversight - responsible for maintaining oversight of all tasks undertaken by TCS POC on a study (site users contact creation in eTrack and CTMS and RAMOS NG invitation process, MUL process, regulatory documents review required for Xpress activation)
  • Preparation and update of study documents and study plans (Monitoring Plan, Site Training Plan, Rater Training Plan, PDNC Plan, Sample Analysis Plan) and technical support during central trial documents creation
  • Supporting central study team in global study coordination activities
  • Support for IM preparation (development of the agenda, coordinating slide preparation) Participation in additional initiatives – acting as a Mentor in Contractors Program, participation in Centralized Monitoring Shadowing
  • Clinical Supplies (i.e
  • Drug) oversight and management.

Clinical Research Coordinator

Osteo Medic s.c.
02.2018 - 10.2021
  • Completion and retention of all case report forms (CRF) with corresponding source documents and correspondence to CROs and sponsors in a timely manner
  • Preparation and management of all required documentation for study start-up
  • Preparation and coordination of pre-study, initiation, interim closeout visits and sponsor audits
  • Interact with Investigators
  • Maintaining of Investigator Site Files and completing all documents required by various sponsors and protocols
  • Ensure adverse events and serious adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary
  • Coordinating the daily clinical trial activities including creating source documents, conduct patient site visits and assure all procedures are performed in compliance with clinical protocol and ICH/GCP standards
  • Managed phase Il and IlI clinical studies for various therapeutic areas: psoriasis, psoriatic arthritis, kidney disease in subject with type 2 diabetes mellitus, type 2 diabetes mellitus, ankylosing spondylitis, rheumatoid arthritis and axial spondylarthritis.

Warehouse Administrator

Clipper Logistics
02.2017 - 11.2017
  • Contact with clients and ASDA sales department
  • Integrating the RedPraire Warehouse Management System with actual warehouse inventory availability
  • Data entry and inventory of all stock involves processing receipts, taking records and documenting the details of all orders
  • Receiving, issuing and dispatching stock, and handling communication between freight companies and warehouse
  • Coordinate supply chain procedures to maximize quality of delivery
  • Training of new warehouse workers and delegating shift duties.

Education

BA Degree in Journalism and Social Communication -

Uniwersytet Warmińsko- Mazurski
01.2012 - 04.2014

Skills

Knowledge of various data entry potrals (InForm, iMedidata, Trialmaster), IRT systems(RAMOS NG, Lilly, MyTrials, Impala, Trident, Bioclinica), training portals (InvestigatorSpace, Firecrest, Longboat) and many other study vendors and customer services, eTrack and Veeva Vaultsundefined

Certificates And Trainings

Good Clinical Practice (Investigator Version)

Personal Information

Date of Birth: 09/10/92

Consent

I hereby give consent for my personal data to be processed for the purpose of conducting recruitment for the position for which I am applying.

Timeline

Study Manager

GSK, Global Clinical Development (GCD) Poland
06.2023 - Current

Study Delivery Specialist

GSK, Global Clinical Development (GCD) Poland
11.2021 - 05.2023

Clinical Research Coordinator

Osteo Medic s.c.
02.2018 - 10.2021

Warehouse Administrator

Clipper Logistics
02.2017 - 11.2017

BA Degree in Journalism and Social Communication -

Uniwersytet Warmińsko- Mazurski
01.2012 - 04.2014

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Emilia Paulina DobkoStudy Manager