Germany
With 18+ years of experience in Clinical Data Management (CDM) and over 7 years advancing into Clinical Data Science (CDS), I specialise in preparing clinical trial data for analysis-ready, scientifically meaningful insights. Alongside data management leadership, I bring deep expertise in Central Monitoring and Risk-Based Quality Management (RBQM) - applying data analytics, KRIs, and DQAs to proactively detect risks and strengthen oversight. I am Certified Clinical Data Scientist (CCDS®), Clinical Data Manager (CCDM®), Medidata Rave® Certified Study Builder and Lean Six Sigma Green Belt, recognized for bridging technical expertise with cross-functional leadership and process optimization. My career spans both sponsor- and vendor-side roles, giving me a 360° perspective on study delivery, partnerships, and regulatory quality. Career Highlights: • Led pivotal submission studies in Immunology, CNS, Respiratory, Cardiovascular, and Oncology - contributing to successful regulatory approvals and launches. • Directed Oracle-to-Rave database migrations for six global trials in under 4 months. • Designed and piloted a 4-way reconciliation framework (IRT, EDC, Central Lab, Specialty Lab) to improve sample traceability, reduce missing samples and more accurate reconciliation outputs. • Applied Central Monitoring and RBQM approaches (CluePoints, Spotfire) to enhance oversight, risk detection, and data integrity across global portfolios. • Managed rescue studies and vendor/EDC transitions, maintaining continuity under accelerated timelines. • Authored and streamlined SOPs/WIs aligned with CQA standards, embedding lean practices across teams. I am committed to advancing future-ready CDM/CDS practices that integrate Central Monitoring, scientific data review, and digital innovation, enabling trials to deliver both clean and clinically meaningful data. Outside of my professional career, I actively volunteer at global sporting events including the Special Olympics World Games, World Aquatics Diving and Swimming, and Ironman. These experiences strengthen my teamwork, adaptability, and commitment to fostering inclusion and resilience - values I also bring to my professional work.
Led CRO and vendor oversight for end-to-end Clinical Data Management across multiple therapeutic areas, including Immunology and Oncology. Managed the full data lifecycle - from EDC setup, integrations, and system updates to interim/final data deliveries and database lock. Served as a core trial team member representing the DM function, providing protocol review, project management, and CDM consulting. Drafted EDC and SDTM specifications, chaired Medical Quality Data Reviews, and conducted SDTM data review in P21. Supported cross-functional teams with system setup, maintenance, and updates. Key Achievements: • Successfully managed Data Management for a complex pivotal study submitted to regulatory authorities, resulting in drug approval and market launch (Spesolimab). • Led the migration of six long-running trials from Oracle to Medidata Rave in less than three months, ensuring business continuity, data integrity, and compliance under accelerated timelines. Key Systems: Medidata Rave EDC, SAS, P21, J-Review, Business Objects, CTMS, IRT Therapeutic Areas: Immunology, Oncology
Delivered and oversaw a team on start-to-end Data Management activities on Medidata Rave EDC across CNS (Ocrelizumab)and Oncology (Atezolizumab) therapeutic areas, supporting both submission-enabling interventional studies and large-scale non-interventional/registry programs. Provided line management and mentoring, and authored/reviewed SOPs/WIs to strengthen Data Management processes and compliance standards. Actively contributed to RFP responses, including study costing and budget proposals, ensuring accurate scoping and alignment with sponsor expectations. Applied process improvement principles to streamline workflows and enhance efficiency in study delivery.
Delivered start-to-end Data Management activities on Medidata Rave EDC, including database setup, integrations, maintenance, and data deliveries. Provided line management and mentoring, and authored/reviewed SOPs/WIs to strengthen Data Management processes and compliance standards. Actively contributed to RFP responses, including study costing and budget proposals, ensuring accurate scoping and alignment with sponsor expectations. Applied process improvement principles to streamline workflows and enhance efficiency in study delivery. Key Achievement: • Led a process streamlining initiative, re-authoring all working instructions in alignment with company CQA guidelines, making Data Management workflows leaner and more compliant. Overcame significant pushback from the existing team resistant to change, successfully embedding new standards across operations.
DM TL : Cognizant (Partnership with Novartis Pharma AG) Took on my first leadership role, overseeing end-to-end Data Management activities for complex cardiovascular studies. Led teams and studies under the Novartis–Cognizant partnership model, balancing sponsor delivery with innovation and process standardization within Cognizant. Key Achievements & Contributions: • Acted as SME for Data Handling Plan harmonization and Completion Guidelines, ensuring alignment between Novartis and Quintiles standards. • Served as SME for CREDI, a document repository, supporting consistent and compliant document management practices. • Successfully managed three rescue studies, stepping in after abrupt departures of lead data managers and team leads, stabilizing delivery and ensuring timelines were met. • Built and developed teams primarily composed of fresh graduates and bench resources with limited domain knowledge, providing training, guidance, and hands-on mentoring to enable them to deliver on high-complexity studies. • Strengthened leadership capabilities through line oversight, people development, and study-level accountability - establishing a foundation for future portfolio leadership roles. Systems: Oracle RDC, I-Review, and other client-specific applications Therapeutic Areas: Cardiovascular (complex studies)