Marie Dreher

* Trial delivery: Lead CRA on 7+ global studies across the full lifecycle — feasibility, start-up, maintenance and close-out — working the cross-functional route between site-level conduct and global trial leadership, clinical science and data management, and converting monitoring signals and emerging risks into actionable escalations. * Systems ownership: eTMF and CTMS subject matter expert for the cluster and CTMS super user; the monitoring communitys end-user representative in defining document-tracking

* Driving Clinical Trial Success: Expertise across all stages from Feasibility and Start-Up to Maintenance and Close Out. * Boosting Recruitment & Engagement: Designed and distributed a comprehensive quarterly newsletter, keeping the medical team informed and engaged with recruitment efforts. * Optimizing Quality and Processes: Reviewed SOPs, Work Instructions and Job Aids, ensuring compliance with global quality standards and driving process efficiency. * Enhancing Operational Efficiency: Successfully supp

* Trial Support & Insight Capture: Supported investigator-facing trial recruitment across the thoracic oncology territory by conducting data presentations and patient-referral discussions, prioritising sites by reading activation against randomisation performance versus plan, mapping referral routes from regional hospitals into active trials, and capturing structured insights against defined categories.

Monitoring Excellence Team * Supported the transition from the Shared Investigator Platform to an internally built platform integrated with CTMS and eTMF; sites reported satisfaction in post-transition surveys * Optimize site engagement processes by addressing user issues, participating in status calls, managing and analyzing data, reviewing system workflows, evaluating system pilots, and conducting training sessions while maintaining comprehensive documentation and communication.

Monitoring Excellence Team * Support and optimize site engagement processes by addressing user issues, participating in status calls, managing and analyzing data, reviewing system workflows, evaluating system pilots, and conducting training sessions while maintaining comprehensive documentation and communication.

* Supported the company-wide roll-out of Veeva Vault CTMS as monitoring community's representative * Represented the monitoring perspective across successive releases by defining expected system behaviour for drug reconciliation and protocol deviation documentation, executing release testing, working 20+ enhancement requests, and delivering CRA onboarding and learning sessions.

* Trial delivery: Monitoring and study start-up across Switzerland and Germany, working across medical affairs, data management and global study leads; ran pre-trial assessments and site qualification visits feeding country site selection, and reviewed feasibility questionnaires across multiple protocols. * Cross-functional reporting: Established the quarterly recruitment and timelines briefing that medical affairs uses to plan its KOL engagement. * Automation: Automated recurring CRA reporting from EDC,

* Monitoring delivery: Site monitoring across the full study lifecycle on Phase I–III oncology protocols in Germany and Switzerland, from initiation through conduct to close-out, holding 20 active oncology sites at all times. * Risk-based monitoring: Worked under risk-based monitoring from 2015, using source data verification targeted by the study risk assessment. * Compliance: Verified conduct against ICH-GCP and national regulatory requirements, meeting or exceeding defined quality metrics throughout.

Panáková Lab Electrochemical Signaling in Development and Disease Publication: Planar cell polarity signalling coordinates heart tube remodelling through tissue-scale polarisation of actomyosin activity --- https://www.nature.com/articles/s41467-018-04566-1

Thierfelder Lab Mechanisms of Arterioscleroris

Mueller Lab Cell Cycle Mechanisms in Human Embryonic Stem Cells

I study in my own time with no set end date to achieve the following during this journey: - Analytical Depth: Philosophy sharpens critical thinking, supporting complex decision-making in research. - Ethical Insight: Builds a foundation in ethics, enhancing rigor in professional choices. - Broadened

Thesis online @ HU Berlin: http://edoc.hu-berlin.de/docviews/abstract.php?id=43537

Major: Molecular and Microbiology Minor: Forensic Medicine / Virology

Major: Biology Minor: Business Administration / Marketing