KASIA WAJER
London
Summary
Results-driven professional with extensive expertise in leadership, project management, and strategic planning. Proven track record in clinical development and operations, adept at leading and managing global clinical trials across phases I-IV in EMEA, the Americas, and Asia-Pacific. With nearly 20 years of comprehensive experience in clinical and pre-clinical research, excel in complex problem analysis, decision-making, and risk assessment to enhance operational excellence and quality assurance.
Proficient in all stages of clinical trials, including study concept design, protocol writing, feasibility assessments, start-up, monitoring, close-out, final report preparation, and submissions. Demonstrated skills in budget management and cost optimization, with a strong emphasis on clinical innovations. Highly experienced in managing and overseeing CROs and other vendors, as well as procurement processes.
Key therapeutic areas of expertise include Neuroscience, Oncology/Haematology, Metabolic Diseases, Cardiology, Immunology, Infectious Diseases, Nephrology, and Rare Diseases. Possesses in-depth knowledge of ICH guidelines, GCP, the drug development process, and regulatory aspects related to decentralized trials and patient engagement.
Fluent in English, Polish, and Spanish, with a strong cultural sensitivity. Dedicated to utilizing my skills to make meaningful contributions to organizational success
Overview
18
18
years of professional experience
8
8
years of post-secondary education
Work history
Senior Global Project Manager
Jazz Pharmaceuticals/ GW Pharmaceuticals
, UK
01.2020 - Current
- Oversight for Phase II-IV for outsourced Neuroscience trials (starting from Study Concept to DBL/CSR delivery) within Clinical Operations and Global Medical Affairs Operations groups.
- Contributed to portfolio protocol design, study timelines, forecasting and recruitment /patient retention strategies planning.
- Facilitated smooth workflow by maintaining clear communication channels among study team members.
- Negotiated contracts with vendors; resulted in cost-effective services and products.
- Overcame complex project challenges through effective problem-solving techniques.
- Achieved successful project outcomes by implementing risk mitigation strategies.
- Enhanced overall productivity by introducing innovative project management tools.
- Ensured adherence to regulatory requirements for smooth operations across all projects.
- Fostered strong relationships with stakeholders /cross functional team members for improved communication and cooperation ( ie . Medical Affair Team across different countries and regions , Quality Assurance Team , Innovation and Technology, Outsourcing / Contracting vendors )
- Established clear budgets and cost controls strategies to meet objectives.
- Coordinated diverse project tasks, delivering results ahead of schedule.
- Mentor In House CRAs and Junior CTMs and support in their career growth.
- Key Achievements: First Site activation ahead of projected timelines. Designed and oversee sites engagement and recruitment campaign what resulted achieving LPI ahead of targeted timelines. Contributed to development and optimization of electronic dashboard. Contributed in designing DCT Corporate model of Clinical Trials.
Clinical & Development Manager (PM/Sr.PM)
Intercept Pharma
, UK
09.2015 - 10.2019
- Highly involved in corporate Initiatives and processes improvement such as: CRO Oversight Process, Strategic planning for project start up acceleration, Clinical Data Standards Initiative, CRO KPIs aligned to E2E metrics, optimize collaboration between Medical Affairs team/ Clinical Operations, Support process built for patient focus & Site engagement.
- Provided leadership and management for Phase I – III Metabolic Indication and Rare diseases for in-sourced and outsourced trials within projected timelines, budget and to a high-quality standard as per GCP.
- Led vendor selection process and oversaw day by day vendor activities i.e. (IVRS/ IRXS, Central Labs, Specialized Labs, eCOA, Meeting Planners) as per Project management Oversight Plan.
- Led and conducted operational due diligence and comprehensive optimization of the project portfolio, built relationships with internal and external stakeholders (Vendors, KOLs, Investigators and Patients Advocacy groups Globally).
- Contributed to the design and revision of Clinical documents (e.g. Protocols, IB, Patients Materials, Trial study updates and metrics, Study final reports - CSRs).
- Initiated and contributed to the corporate process development: Designed and rolled out processes such as: CRO Selection Guideline, CRO Partnership Oversight process, CTMS platform build, Clinical Operations - Medical Affairs workflow and communication excellence for outsourced studies, Cross functional Project Management Handbook.
Senior Associate/ Global Study Manager
Eisai Ltd. European Knowledge Centre,
, UK
04.2014 - 08.2015
- Provided operational support for outsourced studies (Oncology)
- Served as a Primary point of contact for the CRO, and independently oversaw all project management activities in assigned countries.
- Oversaw assigned study vendors (i.e. Imagine vendor, Central Labs, PK labs, IRT, IMP Supply strategies)
- Liaised between different departments ensuring smooth workflow during projects' execution.
- Achieved project objectives by creating and implementing strategic plans.
- Designed innovative strategies for data collection and prepared comprehensive reports to support data oversight.
- Created and Led Risk Based CRO Monitoring Oversight process, reviewed Monitoring Visit reports, Deviation trends and assessed risk.
- Designed and Oversaw portfolio eTMF review plan for FDA inspection readiness for newly approved product.
SR CRA / Lead CRA
PAREXEL
, UK
10.2012 - 04.2014
- Successfully delivered on tasks within tight deadlines.
- Performed all types of monitoring visits across 3 different EU countries: Poland, Spain, UK.
- Prepared and reviewed essential Documents for IRB / RA submissions.
- Supported Contract Team in negotiations with site budgets and Contract Agreements
- Successfully conducted trial Database review within the timelines.
- Provided appropriate protocol / operational training to HCPs .
- Maintained and Oversaw TMF for inspection readiness.
- Managed risk, escalated Issues / deviations as per GCP requirements.
- Mentored Junior staff.
CRA II / Sr CRA
Novartis Poland
, Poland
11.2011 - 10.2012
Jr CRA - CRA2
PPD Poland
, Poland
07.2007 - 10.2011
Internship Resident: Neuroscience
Salamanca University, Dept. of Biochemistry
, Spain
06.2007 - 06.2007
- Conducted experiments in primary cell cultures of neurons and astrocytes.
- Lab research projects - molecular biology. Used biochemistry techniques such as: western and northern blotting, PCR, RT-PCR, immunocytochemistry for molecular research.
Education
CPD Certificate - Novel Clinical Trial Design in Translational Medicine
University of Cambridge
UK 06.2023 - 12.2023
Certificate of Higher Education - Medical / Pharmaceutical Law and Bioethics
University of Warsaw
Poland 09.2008 - 06.2009
MSc Scholarship - Faculty of Pharmacy
Universidad Salamanca
Spain 01.2005 - 06.2006
Master of Science - Laboratory Medical Science
Collegium Medicum- Nicolaus Copernicus Univesity
Poland 09.2024 - 09.2026
Bachelor of Science - Biomedical Informatics
Medical Science University - L. Rydygier Academy
Poland 09.2001 - 09.2004
Skills
- Leadership skills / Team Leadership and Project Management
- Strategic visioning and Strategic planning
- Database management & Data analysis
- Operational excellence and complex problem analysis
- Decision-Making aptitude
- Risk assessment and mitigation
- Quality Assurance
- Budget management and cost optimization
- Clinical Innovations
- Computer literacy: Microsoft Office , Microsoft Excel, MS Project, Electronic Data Capture (ie Medidata, Oracle, Veeva), eTMF, CTMS, QMS, SharePoint, Power Point Prezi, eCOA, IRT, Data Repository platforms, Smartsheet, Tableau, Collaboration tools: Teams, Zoom
- Fluency in foreign languages: English, Polish, Spanish
- Cultural sensitivity and awareness
Additional Courses / Certifications
2025 - Patient Engagement E- learning Program -DIA
2022 - Project & Portfolio Management for Pharmaceuticals – marcusevans Virtual Course
2021 - Critical Thinking During Risk Assessment - Webinar
2020 - Virtual Clinical Trial – Webinar
2018 - Building Relationship Versatility - Social Styles at Work
2017- Effective Presentations
2016- PTI - Budget Management Clinical Trial
2015- Virtual Team Management
2012- Risk Based Monitoring
2009- ICH - GCP training
2007- PPD Foundation - Introduction to Monitoring Clinical Trials
Timeline
Master of Science - Laboratory Medical Science
Collegium Medicum- Nicolaus Copernicus Univesity
09.2024 - 09.2026
CPD Certificate - Novel Clinical Trial Design in Translational Medicine
University of Cambridge
06.2023 - 12.2023
Senior Global Project Manager
Jazz Pharmaceuticals/ GW Pharmaceuticals
01.2020 - Current
Clinical & Development Manager (PM/Sr.PM)
Intercept Pharma
09.2015 - 10.2019
Senior Associate/ Global Study Manager
Eisai Ltd. European Knowledge Centre,
04.2014 - 08.2015
SR CRA / Lead CRA
PAREXEL
10.2012 - 04.2014
CRA II / Sr CRA
Novartis Poland
11.2011 - 10.2012
Certificate of Higher Education - Medical / Pharmaceutical Law and Bioethics
University of Warsaw
09.2008 - 06.2009
Jr CRA - CRA2
PPD Poland
07.2007 - 10.2011
Internship Resident: Neuroscience
Salamanca University, Dept. of Biochemistry
06.2007 - 06.2007
MSc Scholarship - Faculty of Pharmacy
Universidad Salamanca
01.2005 - 06.2006
Bachelor of Science - Biomedical Informatics
Medical Science University - L. Rydygier Academy
09.2001 - 09.2004
Similar Profiles
Joan BalatbatJoan Balatbat
Laboratory Assistant at Jazz PharmaceuticalsLaboratory Assistant at Jazz Pharmaceuticals
Teryl Nichole NelsonTeryl Nichole Nelson
Senior Clinical Trial Specialist at Advanced Clinical embedded in Jazz PharmaceuticalsSenior Clinical Trial Specialist at Advanced Clinical embedded in Jazz Pharmaceuticals
Amanda TedescoAmanda Tedesco
Sr. Manager, IS R&D Reporting and Business Systems at Jazz PharmaceuticalsSr. Manager, IS R&D Reporting and Business Systems at Jazz Pharmaceuticals
Rebecca DominatoRebecca Dominato
Mid Market Expansion – Client Development Manager at Smartsheet IncMid Market Expansion – Client Development Manager at Smartsheet Inc
Paul ClarkPaul Clark
Front of house team member at Phoenix Theatre, Ambassador Theatre GroupFront of house team member at Phoenix Theatre, Ambassador Theatre Group