ALINA STOYANOVA
Limelette
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
2026
2026
years of professional experience
Work History
Senior Medical Data Specialist
BUSINESS & DECISION LIFE SCIENCES CRO
Diegem
2013 - Current
- Company Overview: Corporation provides broad range of CRO and CDISC services, solutions, and consulting to clients in pharmaceutical, medical device, biotechnology, food, and cosmetics industries.
- Lead DM in various pre- and post-marketing studies: NECTAR-HF, RELIANCE4-Front, OPTI-MID2, UNTOUCHED, SMART MSP, SMART Registry, POLAR ICE, MODULAR ATP
- Tracking timelines and study prioritization, provide data and study matter expertise to different stakeholders. Providing data management subject matter expertise to project team members during all phases of project life cycle.
- Analyzed clinical trial data to ensure accuracy and compliance with regulatory standards.
- Developed and maintained databases for tracking patient information and study progress.
- Conducted quality assurance checks on datasets to identify discrepancies and resolve issues.
- Trained new team members on data entry protocols and software tools used in studies.
- Managed sensitive information responsibly, adhering to strict security protocols and maintaining confidentiality at all times.
- Managed documents by organizing forms, making photocopies, filing records, preparing correspondence, and creating reports.
- Streamlined data management for improved decision-making, through effective organization and storage of complex datasets.
Associate Clinical Trial Manager
BOSTON SCIENTIFIC/ GUIDANT EUROPE
Diegem
01.2019 - 03.2023
- LSS 4-SITE: 2019 -2020 Tracking of study milestones and study prioritization for closure activities. Overseeing and managing CRO, study fully outsourced to NAMSA. Work with regulatory team on the FDA post approval mandated study requirements. Writing and final submission of final annual report & CSR. Regular and final updates on Clintrial.Gov
- NAVIGATE X4: 2020-2021 Managing core team and facilitating expedite study closure activities (collaboration and guiding each function team member, tracking milestone, sending site close-out letters, archiving and updating Clintrial.Gov with final results..)
- ASE study-2022-2023 Facilitating the final device accountability and reconciliation, leading the small core team until the very last moment of study closure and archiving. Helping with final report.
- Up to date and active in MyLearning CUR-22037
- Managed large-scale data migration projects, ensuring seamless transitions with minimal downtime or disruptions.
- Streamlined data management workflows for increased efficiency and faster project completion.
- Developed custom algorithms to support advanced analytics capabilities, driving business insights and growth strategies.
- Improved data accuracy by implementing rigorous quality control measures and data validation processes.
- Led the evaluation, selection, and implementation of cutting-edge tools for improved database management and analysis capabilities.
- Established strong relationships with key stakeholders across various departments to align on shared objectives related to optimal use of available resources.
Clinical Data Coordinator Consultant
GSK
01.2010 - 01.2012
- Supervised data management activities for HPV vaccine studies. Performed final QC of data managers’ cleaning. Specified and reviewed required CRF database listings. Lead coordination and pre-analysis meetings. Supported and mentor the training of junior DM in association with the Head DM manager. Represented Data Management in multi-disciplinary taskforces of process improvements and proper functionality of technical project parts.
Clinical Data Manager Consultant
Tibotec - Division of Johnson & Johnson Pharmaceutical
01.2007 - 01.2010
- Directed all aspects of Tibotec trials from CRF design through database lock activities. Successfully locked several phase I paper studies of variable complexity. Oversaw data management activities performed by CRO companies. Coached CRO partners on Tibotec specific tasks. Mentored new employees. Administered on going and final QC of SAS databases provided by the external parties. Reviewed protocol and amendments, DM Budgets, proposals, and contracts.
Data Manager and IVRS Project Associate
S-CLINICA
01.2003 - 01.2007
- Company Overview: Provider of advanced technology solutions and services to pharmaceutical and biotechnology companies. Offers EDC and IVR-IWR services.
- Teamed with 3 data managers to direct paediatric and vaccine trials. Performed full-cycle project management. Reviewed data, issued queries. Programmed using SQL and SAS. Set up drug supply management system and prepared randomisation functional specification. Implemented IVR/IWR by using specific study set up tool. Trained investigators and CRAs to use IVRS system. Resolved supply chain issues in North America and Europe. Ensured tracking of supplies from the depot to the final user. Regularly participated in multiple international investigators meetings. Prepared presentations and coaching sessions on IVR-IWR systems.
Clinical Trial Data Manager
EUROPEAN ORGANISATION FOR RESEARCH & TREATMENT OF CANCER
01.2001 - 01.2003
- Company Overview: Independent research organisation funded through grants and national cancer leagues.
- Collaborated with multiple hospitals and oncologists in Europe for Genito-Urinary cancer group. Ensured monthly onsite evaluation with oncologists. Managed in-house data system. Verified query management and resolution.
Education
M.D. - Bioinformatique
Universities of The French Community of Belgium
2001
Diplôme d’études Approfondies (DEA) - Biologie Moléculaire et Biotechnologie
Université Libre De Bruxelles
06.2000
Master of Biological Science -
Sofia University
Sofia Bulgaria09.1997
FCE - undefined
University of Cambridge
Skills
- EDC system: Inform, Rave, MEDNET,
- CTMS, VEEVA VAULT, Miro
- Software development: SQL, SAS base, Pearl,Nushell
LANGUAGES
English
French
Dutch (Basic)
Timeline
Associate Clinical Trial Manager
BOSTON SCIENTIFIC/ GUIDANT EUROPE
01.2019 - 03.2023
Clinical Data Coordinator Consultant
GSK
01.2010 - 01.2012
Clinical Data Manager Consultant
Tibotec - Division of Johnson & Johnson Pharmaceutical
01.2007 - 01.2010
Data Manager and IVRS Project Associate
S-CLINICA
01.2003 - 01.2007
Clinical Trial Data Manager
EUROPEAN ORGANISATION FOR RESEARCH & TREATMENT OF CANCER
01.2001 - 01.2003
FCE - undefined
University of Cambridge
Senior Medical Data Specialist
BUSINESS & DECISION LIFE SCIENCES CRO
2013 - Current
M.D. - Bioinformatique
Universities of The French Community of Belgium
Diplôme d’études Approfondies (DEA) - Biologie Moléculaire et Biotechnologie
Université Libre De Bruxelles
Master of Biological Science -
Sofia University
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