Mariya Barakova
Sofia
Summary
Associate Project Leader with expertise in managing cross-functional teams to deliver projects on time and within budget. Utilises project management tools to enhance performance tracking and ensure alignment with client expectations, driving customer satisfaction and repeat business. Develops risk assessment strategies and fosters a culture of continuous improvement, committed to achieving operational excellence and measurable results.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Associate Project Lead
Comac Medical
Sofia
06.2025 - Current
- Assisting PL in obtaining comprehensive project management plans and related attachments from Sponsor, ensuring alignment with project requirements.
- Coordinating internal and external meetings with Sponsor to facilitate effective communication and project progression.
- Support in performing reviews of the final documents to verify correctness and completeness, as per regulatory approval.
- Maintenance of Investigator Site File (ISF) and other essential study documents.
- Support in reparation for site qualification visit, when contracted.
- Support preparation for Site Initiation Visits (SIVs).
- Organising and distributing training materials for project-specific training.
- Gathering relevant information after assignment to new project.
- Support in performing activities with feasibility team, related to the project, if required.
- Support in collecting by CRA of site-specific documentation.
- Ensure effective and proper communication between all parties involved in the project.
- Arranging translation services for project-specific documents.
- Liaison with study teams and medical professionals to ensure project progression and successful delivery.
Project Manager
Fidelis Research, a BioIVT company
Sofia
04.2023 - 06.2025
- Overall Management and oversight of assigned company projects on a global level.
- Project Management Plan Preparation.
- Preparation of a set of project essential documents.
- Preparation of project presentations.
- Facilitated communication with site personnel to ensure project alignment and issue resolution.
- Coordinated communication with sponsors to provide project updates and address inquiries.
- Conduct meetings with medical personnel.
- Drafted contracts for project agreements and partnerships.
- Delegated assignments to Project Associates and followed up to ensure timely completion of tasks.
- Attendance of accompanying site visits for quality check purposes.
- Preparation of standard operating procedures.
- Maintenance of company's data trackers.
- Correspondence with monitors (CRO) on behalf of the site staff related to the SMO projects.
- Entered data into electronic systems for accuracy and efficiency.
- Onboarding and training of new hires.
Clinical Trials Coordinator
CLINECA EAD
Sofia
05.2021 - 04.2023
- Coordinated clinical study timelines to meet critical milestones and escalated issues jeopardising timelines and deliverables.
- Coordinated patient and CRO/Sponsor visits, facilitating smooth study processes.
- Participated in cross-functional study teams, liaised with other functional areas to accurately coordinate clinical study activities.
- Provided feasibility and site selection support, ensuring rapid and correct completion of the study questionnaires.
- Assisted in the correspondence with subjects, sponsor, site study team, CRO, Institutional staff and EC.
- Assisted in collecting documents during the study start-up.
- Managed (Central) laboratory related processes.
- Performed study procedures designated for the Study Coordinator.
- Trained and retrained investigational site staff.
- Preparation of the respective subjects' visit kit(s) and provision to the study team, Lab packing and shipment; sample storage.
- Managed study medication, ensuring accountability for expiration dates, IV(W)RS calls, and provision/collection of assigned IMP kits.
- Assisted in preparation and completion of the source documents, timely completion of eCRFs, study files management.
- Coordinated resolution of all data queries.
- Executed document management tasks to ensure accurate record-keeping.
- Maintained adequate inventory of study supplies.
R&I Research Management Coordinator
Salford Royal Hospital NHS Foundation Trust
Manchester, GB
11.2020 - 04.2021
- Ensured that all research studies are adequately costed and contracts and agreements are in place.
- Support research study management and delivery.
- Support feasibility and risk assessment of proposed research.
- Participate in developing, maintaining, reviewing, and managing R&I systems, including the LPMS.
- Oversee compliance with regulators and EC.
- To ensure that all amendments are processed in a timely manner and in accordance with regulatory and legislative regulations.
- To act as a resource for advice on governance approvals and research monitoring.
- Advise and develop training information and courses on research governance and best practice.
- Collaborated with R&I Department members to review new submissions, establishing resource implications and addressing research management issues.
- Coordinated with pharmacy, radiology, and pathology to streamline research processes.
- To ensure that all research applications are processed in a timely manner in accordance with regulatory and legislative regulations.
- Attend, and contribute to, R&I meetings at local, regional, and national level.
- To support the development of new studies in their early stages.
Sponsorship, Support & Compliance Administrator
Salford Royal Hospital NHS Foundation Trust
Manchester, GB
06.2019 - 11.2020
- Liaised with medical and regulatory professionals to facilitate study approvals and adherence to guidelines.
- Coordinated monitoring visits to ensure compliance with study protocols.
- Conducted audits of clinical trial units, laboratories, and inpatient pharmacies on hospital grounds.
- Organising monitoring and audit schedules.
- Writing up monitoring reports.
- Monitoring of studies.
- Managed and organised study folders, ensuring accurate documentation and accessibility.
- Creating logs and other templates for sponsored studies.
- Arranging SIVs and Close-Out visits.
- Monitor recruitment rates for the different studies.
- Managing study spreadsheets and data.
- Submitting APRs and Final Reports to the committees and regulators.
- Assisted with archiving procedures.
- Perform audits on hosted studies.
- Assisted in updating R&I Standard Operating Procedures to reflect current practices.
- Coordinating a broad range of tissue banks called NCARC (Northern Care Alliance Research Collection).
Clinical Trials Administrator
The Royal Oldham Hospital
Manchester, GB
05.2018 - 06.2019
- Managed over 30 studies in Diabetes and Cardiology division, ensuring compliance and effective coordination.
- Executed daily CTA responsibilities, including booking patient appointments and ordering sample collections.
- Process paperwork according to FDA, ICH and GCP regulations.
- Maintained investigator site files by organising and updating essential documents.
- Developed new monitoring systems to enhance overview and tracking of each study's progress.
- Assisted with setup for SIVs and monitoring visits, facilitating smooth transitions between study phases.
- Help with close out of studies once completed.
- Screening for new patients.
- Processing new patients into our trials database.
- Creating patient files and localising study documents.
- Familiarising myself with the different protocols and contracts for all studies to meet every study's requirements.
- Archived old studies by systematically filing and storing documents for future reference.
Education
Pharmaceutical Science - BSc -
University of Huddersfield
United Kingdom01-2016
Skills
- Client Relationship Management
- Risk Assessment
- Project Documentation
- Team Collaboration
- Budget Management
- Stakeholder Engagement
- Communication Skills
- Cross-functional Leadership
- Adaptability
- Time Management
- Problem Solving
- Risk Management
Certification
- ESOL Cambridge English Exams - FCE and CAE (B2, C1 level)
- Research Star of the Month Certificate (November 2018)
- Clinical Research Associate
- Remote and Centralized Trial Monitoring
- Clinical Trials Project Management Program (February 2025)
Languages
Bulgarian
Proficient
C2
English
Proficient
C2
Hobbies and interests
- Creative writing.
- Reading books and attending book club meetings to socialize with other likewise readers.
Timeline
Associate Project Lead
Comac Medical
06.2025 - Current
Project Manager
Fidelis Research, a BioIVT company
04.2023 - 06.2025
Clinical Trials Coordinator
CLINECA EAD
05.2021 - 04.2023
R&I Research Management Coordinator
Salford Royal Hospital NHS Foundation Trust
11.2020 - 04.2021
Sponsorship, Support & Compliance Administrator
Salford Royal Hospital NHS Foundation Trust
06.2019 - 11.2020
Clinical Trials Administrator
The Royal Oldham Hospital
05.2018 - 06.2019
Pharmaceutical Science - BSc -
University of Huddersfield