Marta Mazur

Pediatric and Specialty Vaccines

• Responsible for the management and conduct of the complex paediatric study and 2 smaller projects on lactating women and their infants.
• Development and management of project plan and study budget, ensuring targets are met through regular review and tracking whilst monitoring quality metrics so standards are maintained.
• Uncertainties management, implementation of contingency and corrective/preventive action plans.
• Development of study documents (Protocol, Study Operations Manuals, Informed Consent Forms, Monitoring Plans and other study manuals).
• Effectively communicating and collaborating with all stakeholders and cross-functional teams.
• Reporting of project information to the applicable stakeholders
• Overseeing all aspects of trial conduct from study start-up through close-out with the emphasis on timelines, quality and costs.
• Responsible for selection and oversight of vendors, including contact negotiations, progress reports and risks management.
• Development of regulatory documents to ensure compliance with Good Clinical Practice guidelines and other applicable Standard Operating Procedures.
• Leading and motivating cross-functional teams.

• Overseeing study activities (investigator recruitment, start-up, enrolment, monitoring, data collection, reporting).
• Managing and main contact for 14 CRAs based in Serbia, Czech Republic, UK, France, Norway, Belgium, Germany, Portugal, Poland and within the Netherlands.
• Working with the Clinical Project Manager, Global Team Leader to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues.
• Facilitate communication with global partners and key therapeutic area investigators when issues arise that affect multiple projects and/or the entire Therapeutic Area.
• Assisting with identification, screening, and qualification of investigators.
• Act as liaison with participating sites to convey project information and answer questions, troubleshoot, advise, and follow up on study progress with site/local CRAs
• Performing site qualification, initiation, routine monitoring, closeout visits and CRO monitoring oversight/co-monitoring visits in accordance with GCPs and applicable SOPs to assess the safety and efficacy of investigational products and to determine protocol and regulatory compliance.
• Act as a coach for inexperienced CRAs.
• Participate in and/or develop clinical monitoring training methods, documents or tools for investigative sites and CRO partners.
• Development and review of study case report forms, informed consents, source documents, worksheets, study reference manuals, monitoring guidelines, monitoring plans, newsletters, and other monitoring tools as related to clinical protocols.

CEVA- Clinical Event Validation and Adjudication