Fathima Maliyekkal

Data Manager Clinical Trial Assistant @Department Of Oncology, University Of Oxford

Oxford, GB

Assisting in the coordination and administration of early-phase oncology clinical trials, ensuring compliance with regulatory requirements and study protocols.· Managing and reviewing Case Report Forms (CRFs) for accuracy and completeness, contributing to 100% compliance during monitoring visits.· Handling Trial Master File (TMF) documentation, maintaining a 98% audit-readiness score through continuous quality control.· Coordinating and supporting site monitoring visits, ensuring all required documents are available and follow-up actions are addressed promptly.· Assisting in regulatory and ethics submissions, contributing to 10+ successful document packages with no major revisions requested.· Utilizing Medidata Rave and Veeva Vault for EDC and document management, improving data entry accuracy and tracking efficiency.· Supporting patient recruitment and retention activities, including pre-screening support and distribution of trial materials.· Organizing and minuting study meetings, including SIVs and internal updates, ensuring action points are documented and tracked.· Collaborating with research teams and clinical sites to optimize workflows, contributing to a 30% improvement in trial document turnaround time