MS office, CTMS, IWRS, eCRF
Joanna Stanowska
Country Head/Project Manager
Warsaw
Summary
Resourceful Project Manager with 14 years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Knowledgeable in accounting principles, bookkeeping, budget, and financial management.
My proficiency spans across various therapeutic areas, including Phases I, II and III in Neurology, Endocrinology, Immunology, Cardiovascular, Nephrology, Oncology, Hematology, Internal Diseases, Rheumatology, Psychiatry, and Rare Diseases studies.
Overview
14
14
years of professional experience
3
3
Languages
Work History
Country Head/Project Manager
Tigermed
01.2022 - 06.2025
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for clinical trails projects.
- Met project deadlines without sacrificing build quality or workplace safety.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
- Negotiated and managed third-party contracts related to project deliverables.
- Fostered a culture of innovation and creativity within the project team, leading to improved problem-solving capabilities and enhanced outcomes.
- Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
- Created accurate budgets based on resource requirements, allowing for optimal allocation of funds across all aspects of the projects.
- Enhanced team performance with targeted training programs, addressing skill gaps and promoting professional development.
- Optimized project schedules, identifying critical path tasks and reallocating resources to maintain momentum.
- Completed projects within tight deadlines, coordinating team efforts and prioritizing tasks effectively.
- Reduced project costs, negotiating contracts with suppliers and optimizing resource allocation.
- Improved client relationships, consistently meeting or exceeding project expectations and maintaining open lines of communication.
- Identified plans and resources required to meet project goals and objectives.
- Monitored project performance to identify areas of improvement and make adjustments.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
Clinical Project Manager/Project Manager
Clinscience
04.2018 - 12.2021
- Enhanced patient safety during clinical trials with rigorous monitoring and strict adherence to protocols.
- Optimized resource allocation across multiple concurrent projects by utilizing advanced scheduling tools.
- Established a culture of excellence within the team, leading by example and fostering an environment where high-quality work was consistently delivered.
- Conducted thorough risk assessments for each project, proactively mitigating potential issues before they escalated.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
- Implemented innovative strategies to improve patient recruitment and retention rates in clinical studies.
- Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
- Collaborated closely with medical experts, investigators, and external partners to ensure accurate data collection in line with research objectives.
- Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
- Streamlined data management processes for efficient analysis and reporting of results from clinical studies.
- Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies.
- Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
- Improved clinical trial efficiency by streamlining project management processes and implementing best practices.
- Coordinated site visits and audits for ongoing quality assurance during all phases of the clinical trial process.
- Lead regular meetings with the clinical team to gather updates on study, country, and site-level status and priorities, addressing all clinicalrelated issues. Attend both internal and external project team meetings to present and discuss the status of ongoing clinical activities and challenges.
- Coordinate the preparation of the Informed Consent Form and other patient-facing materials, including clinical input for master versions, customization for country- and site-specific versions, managing translations, and distribution among project team members, while tracking each step.
Clinical Project Manager
Accelsiors
04.2016 - 03.2018
- Maintain awareness of the clinical activities' scope for assigned studies.
- Own all clinical deliverables, ensuring timely achievement of clinical milestones, while serving as the primary contact for all clinical activities and issues.
- Prepare and deliver targeted training sessions for the clinical team.
- Develop and maintain study-specific clinical tools, templates, plans, and trackers throughout the project lifecycle.
- Lead regular meetings with the clinical team to gather updates on the study, country, and site-level status and priorities, addressing all clinical-related issues.
- Oversee start-up activities such as site feasibility assessments, site selection visits, essential document collection for regulatory submissions, negotiations for site contracts and budgets, attendance at Investigators' Meetings, and delivery of clinical presentations, as well as developing and managing Investigator Site File templates, conducting Site Initiation Visits, activating sites, and formulating the patient recruitment plan.
- Manage study conduct.
- Oversee study closure activities including database locking.
- Review and deliver Monitoring Visit reports to the Sponsor with appropriate tracking.
- Conduct co-monitoring visits to highenrolling sites and/or ad hoc visits as required due to site issues.
Clincal Research Associate
ICON
02.2013 - 03.2016
- Collaborated with multidisciplinary teams to drive project success and achieve objectives.
- Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines Conducting regular site visits to monitor trial activities and data collection.
- Reviewing and analysing clinical trial data for accuracy and completeness.Developing and maintaining study timelines and budgets.
- Providing training to study staff on study protocols and GCP guidelines.
- Reviewing and approving study-related documents, such as informed consent forms. Conducting source data verification and ensuring data quality.
- Managing trial supplies and drug accountability.
Clinical Research Associate
Accelsiors
01.2011 - 01.2013
- Facilitated coordination of Ethics, Regulatory, and Research and Development submissions.
- Negotiated contracts and budgets with investigative sites. - Prepared patient documents in accordance with country regulations.
- Organized the translation of study-specific documents required for submission.
- Identified investigators and national coordinators with appropriate qualifications.
- Participated in regular team meetings and teleconferences.
- Updated tracking systems, where applicable, to ensure precise study reporting to the Sponsor.
- Conducted Site Selection Visits (SSV).
- Executed Site Initiation Visits (SIV).
- Performed Monitoring Visits (MV).
- Managed Close-Out Visits (COV).
- Ensured precise documentation and reporting of Adverse Events and Serious Adverse Events.
- Reviewed all eCRF pages and compared them with source documents.
- Communicated any deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to investigators.
- Maintained the Trial Master File.
Education
No Degree - Professional Diploma in Project Management
Project Management Academy
Warsaw 04.2001 -
Post-Graduate Certificate - Occupational Health And Safety
University of Life Sciences
Wroclaw, Poland 04.2001 -
Master of Science - Chemistry
University of Technology
Wroclaw, Poland 04.2001 -
Skills
Project management
Project planning
Project planning and development
Project tracking
Risk management
Central monitoring
Regulatory
Strong analytical and problem-solving skills
Strategic planning
Team collaboration
Client relations
Data analysis
Budgeting and forecasting
Root-cause analysis
Vendor sourcing
Stakeholder communications
Cross-functional collaboration
Conflict management
Software
Timeline
Country Head/Project Manager
Tigermed
01.2022 - 06.2025
Clinical Project Manager/Project Manager
Clinscience
04.2018 - 12.2021
Clinical Project Manager
Accelsiors
04.2016 - 03.2018
Clincal Research Associate
ICON
02.2013 - 03.2016
Clinical Research Associate
Accelsiors
01.2011 - 01.2013
No Degree - Professional Diploma in Project Management
Project Management Academy
04.2001 -
Post-Graduate Certificate - Occupational Health And Safety
University of Life Sciences
04.2001 -
Master of Science - Chemistry
University of Technology
04.2001 -
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