Magdalena Anna Pniewska Email & Phone Number

Warsaw, Pl

• Successfully managed the project as Global Project Leader for a complex clinical trial in Oncology with a rare indication• Demonstrated strong leadership by coordinating global cross-functional teams and resources effectively• Achieved on-time delivery while maintaining high-quality standards• Kept the customer satisfied by effectively communicating progress and addressing concerns• Navigated challenges associated with the rare indication and complex design, showcasing adaptability and problem-solving skills• Implemented strategic planning to ensure efficient execution of the study, including vendor set-up and oversight

Warsaw, Mazowieckie, Poland

• Contribution to Interim DBL achieved on time• Clinical Study Report development coordination for dedicated areas• Support of regulatory submission of study results to Authorities• Regulatory Inspection Support Team Lead for the study with direct support of successful PMDA inspection • Operational management of internal and external countries local teams• QI/CAPA implementation• Mentoring and supporting junior colleagues

Warsaw, Mazowieckie, Poland

• Contribution to primary DBL achieved on time• Close collaboration with internal and external partners in start-up, maintenance and close out of studies• Direct management of outsourced countries teams to ensure appropriate level of CROs and affiliates oversight is maintained and documented throughout the lifecycle of the study• Creation and maintenance of delegated study documents and external service provider related documents (proposals, specifications, contracts, presentations)• Proactive contribution to risk and issue identification, development of mitigation and action plans for identified risks and issues

Warsaw, Masovian District, Poland

• Lead Project Specialist on the study, overseeing two Project Specialists and supporting Project Leaders with anticipating potential issues and coordinating work of the overall project good • Acting as Portfolio Project Specialist, which included: • Overall support of the client’s goals and objectives • Seeking opportunities to improve project efficiencies for all projects within the Portfolio • Facilitating standardization of Client’s processes and standards across all projects within the Portfolio • Providing internal support to Strategic Accounts Management team for Alliance tasks as well as Functional Leaders working on projects within the Portfolio • Initial escalation point for study level issues for projects within the Portfolio • Mentoring and training of Project Specialists as they transition to projects within the Alliance • Mentoring and training of Project/Clinical Leads for initiatives and processes • Serving as the liaison for all teams working across the Portfolio and sharing knowledge gained from previous experiences • Acting as CTMS Data Exchange Coordinator at the Portfolio level

Warszawa, Woj. Mazowieckie, Polska

• Supporting initial set-up of systems• Providing initial resource plan and further resource management • Maintaining project schedule and adjusting to changing timelines• Creating and update of project managements plans• Compiling information for various project meetings• Review of cost invoicing• Creating and managing trackers feeding data from multiple source reports• Supporting high TMF quality maintenance• Creating enrollment projections/forecasts• IxRS support in access granting and reporting

Kielce, Swietokrzyskie District, Poland

- optimizing work flow, reducing error rates and ensuring maximum pharmacy efficiency- supervising pharmacy staff to provide excellent patient service and safety across all shifts- cooperating with health care professionals to monitor, review and evaluate the effectiveness of therapy

Master Of Science In Pharmaceutical Sciences, Pharmacy

• Strong background in pharmacology, pharmacokinetics, pharmacoeconomics and epidemiology • Comprehension of EMA and ICH regulations (GMP.

Master'S Degree, Farmacja

Activities and Societies: Samorząd Studentów CMUJ, Młoda Farmacja Kraków, Koło Enologiczne, Koło Biologii Molekularnej