Martyna Biernacka
Summary
Versatile pharma professional with over 6+ years of experience in highly regulated pharmacovigilance and clinical trial area. Proven ability in clinical project coordination, monitoring performance and quality metrics to maximize compliance and customer satisfaction. Strong communication skills, fluent in English and Polish, basic command of spoken German, intermediate in reading, willing to advance.
Overview
12
12
years of professional experience
Work History
Clinical Trial Coordinator
Fortrea
09.2022 - Current
- Managed multiple projects concurrently without compromising quality or attention to detail
- Reviewed and updated project metrics (study milestones, recruitment metrics, training, document completeness, upload timelines, data management metrics)
- Maintained and overseen study documentation in the eTMF (uploaded and classified study documents, performed periodic quality checks, followed up with the study team for timely issue resolution; reconciled the eTMF at study closure)
- Tracking and escalated risks, issues, and protocol deviations; actions and decisions; monitoring the quality events inside the QMS
- Disseminated study-related information, including project updates and metrics to sponsors- client reporting
- Facilitated study team internal, and external communication and collaboration with different stakeholders (sponsors, vendors, site staff) using multiple communication platforms (Webex and MS Teams meeting, outlook)
- Prepared project documentation, eg. blast emails, newsletters, meeting minutes, drafted project plans
- Provided, revoked and reconciled system access (EDC, CTMS, eTMF, IRT, Sharepoint sites; set-up
- Overseen the project resources by maintaining Project Training Matrix, RACI Matrix, Project Directory, reviewing the time analysis reports (TAR)
- Supported the Project Lead to prepare for audits and/or investigations, including creation of storyboards to document issues that may occur during the project lifecycle; supported study team to ensure timely closure of audit/inspection CAPAs
- Worked with Project Lead to assist with financial tracking and reconciliation
Clinical Operations Specialist Associate
Abbott Medical
01.2020 - 03.2022
- Assisted monitors with site staff training to enforce quality, safety and regulatory guidelines
- Collected, arranged, and entered information into database system (CTMS, DMS)
- Evaluated clinical study documentation for completeness and appropriateness of inclusion into eTMF
- Maintained communication with study sites to report performance, collect study documentation, resolve issues, and request outstanding information
- Monitored the project metrics and key performance indicators
Safety Data Management Specialist/Safety Officer
Pfizer
10.2017 - 12.2019
- Monitored and reported adverse events following drug use
- Processed safety information in a global safety database (coding of adverse events, suspect products, laboratory tests, medical history) coming in Polish, English and German
- Determined the appropriate workflow for case processing to ensure compliance with timelines, business partners and regulatory authorities
- Led the global project to evaluate products for which the company keeps marketing authorization
- Liaising with internal departments ans senior management to report project progress and deliver high quality evaluation in a timely manner
- Enhanced team productivity by providing consistent feedback and guidance on performance goals.
- Assessed and tracked risks and issues; troubleshooting
- Ensured that the procedures and processes are maintained and documented in alignment with the company SOPs, global polices and local regulations and requirements
PhD Researcher/Biologist
Institute Of Biochemistry And Biophysics
10.2011 - 12.2016
- Mentored MSc and PhD students, associate supervisor of three MSc theses
- Performed molecular, microbiological and bioinformatics analyses in scope of research projects
- Review of scientific literature and preparing manuscripts for publication
- Responsible for purchasing reagents and scientific equipment
Education
Ph.D. - Molecular Biology, Microbiology
Institute of Biochemistry And Biophysics
Warsaw, Poland01.2016
Master of Science - Biotechnology
University of Life Sciences
Warsaw, Poland10.2010
Bachelor of Science - Biotechnology
Athlone Institute of Technology
Athlone, Ireland; Erasmus Program.09.2009
Skills
- Project management abilities
- Analytical and critical thinking
- Attention to details and deadlines
- Risk and Quality Management
- Knowledge of ICH GCP and GDP
- Tools: MS Office, Clinical Trial Management System (Siebel and Veeva Vault CTMS), Veeva Vault eTMF, EDC (Medidata RAVE), Argus Safety Database, Xcellerate - risk-tracking applications
Languages
Polish
Bilingual or Proficient (C2)
English
Advanced (C1)
German
Elementary (A2)
Timeline
Clinical Trial Coordinator
Fortrea
09.2022 - Current
Clinical Operations Specialist Associate
Abbott Medical
01.2020 - 03.2022
Safety Data Management Specialist/Safety Officer
Pfizer
10.2017 - 12.2019
PhD Researcher/Biologist
Institute Of Biochemistry And Biophysics
10.2011 - 12.2016
Ph.D. - Molecular Biology, Microbiology
Institute of Biochemistry And Biophysics
Master of Science - Biotechnology
University of Life Sciences
Bachelor of Science - Biotechnology
Athlone Institute of Technology
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