Joanna Mikolajczyk Email & Phone Number

Adept at leading and overseeing assigned clinical trials, consistently exceeding clinical trial metrics and expectations, delivering results with quality and within required timelines ensuring all phases of the trial meet deliverables. Played a key role in driving activities performed by CRAs/IHCRAs team. Conducted site oversight and ensured inspection readiness for high-quality clinical trials following ICH-GCP, standard procedures and applicable regulations. Holds key role as the Clinical Trial Manager in global department since 2018 with more than 12 years of clinical research associate experience in CRO or Pharma company and around 18 years in clinical trials. Skilled in trial feasibility process and building cross-department collaboration with different stakeholders such as regulatory affairs, medical affairs, ethics committees, safety, vendors and data management. Strong background in regulatory submission, preparation submission packages and contract negotiations. Excellent understanding of the clinical trial process including monitoring and site management in various therapeutic areas with focus on keeping the solid site relationships and investigator engagement.Committed to ensuring the successful execution of clinical trials while maintaining compliance with regulatory requirements. Throughout my career, I have gained extensive experience working in international and cross-functional teams across various phases and therapeutic areas such as oncology, cardiology, dermatology, immunology and respiratory diseases, effectively collaborating to drive project success. Continuously seeking opportunities for professional growth and improvement in both practice and career.