Dr Aylin Corus PhD, MSc

• Provide strategic operational leadership across regional and multi-country clinical programs, ensuring delivery against quality, compliance and business objectives.

• Partner with senior project leaders, functional leads and external stakeholders to drive study delivery and operational excellence.

• Develop and implement recruitment, retention and site engagement strategies supporting successful study outcomes.

• Contribute to bid defence activities and strategic planning for multinational clinical development programs.

• Drive proactive risk identification, issue escalation and mitigation strategies to support program success.

• Served as strategic TMF Subject Matter Expert supporting global Clinical Trial Teams.

• Led risk-based TMF quality reviews, completeness assessments and inspection readiness activities.

• Drove TMF governance initiatives and documentation quality improvements across multinational studies.

• Partnered with stakeholders to identify and remediate critical documentation gaps.

• Supported TMF strategy development throughout the clinical trial lifecycle.

• Supported end-to-end study delivery across multiple clinical programs throughout Europe and the United Kingdom.

• Managed ethics and regulatory submissions, site coordination and operational planning activities.

• Supported patient recruitment initiatives, vendor management and study execution.

• Contributed to compliance, quality management and operational risk mitigation.

• Supported global HIV clinical programs across Europe, South Africa and the United States.

• Acted as Subject Matter Expert for Veeva Vault eTMF, CTMS and EDC systems.

• Coordinated external vendors including ICON, PPD, Signant Health and BioClinica.

• Supported operational oversight, documentation quality and successful study delivery.

• Led Phase I–III clinical development activities supporting program strategy, operational planning and study execution.

• Directed audit readiness, CAPA activities and quality management processes.

• Authored SOPs, study protocols, manuals and scientific documentation.

• Collaborated with multidisciplinary stakeholders across clinical development, regulatory and operational functions.

• Reviewed medico-legal cases to assist in provision of scientific and medical evidence summaries.
• Prepared literature-based expert documentation to support legal case evaluations.
• Compiled written evidence to facilitate comprehensive legal reviews.

• Supported global Medical Affairs studies across EUMEA.

• Served as eTMF Subject Matter Expert during the transition to Veeva Vault eTMF.

• Coordinated regulatory authority submissions, ethics approvals and study documentation.

• Supported Rare Disease programs including the LEMS Registry and MPS VI Clinical Surveillance Program.

• Conducted TMF and ISF quality reviews supporting audit and inspection readiness.

• Established compliant Trial Master File structures aligned with ICH-GCP and regulatory requirements.

• Supported remediation and documentation quality improvement initiatives.

• Conducted clinical and translational research in radiation oncology, treatment planning and patient outcome assessment.

• Collaborated with oncologists, physicists and multidisciplinary clinical teams.

• Contributed to proton therapy and advanced radiotherapy research.

• Completed doctoral research in Biomedical Physics focused on treatment planning optimisation and radiation therapy.

• Published scientific research and presented findings within academic and clinical environments.

• Supported teaching, mentoring and research supervision activities.

• Supported problem-solving and coordination across multidisciplinary healthcare and research projects.
• Produced and evaluated key operational metrics including enrolment, queries, data quality, and site start-up status.
• Contributed to compliance with SOPs, controlled documents, and working instructions.
• Identified and escalated study risks to Trial Specialists and Study Managers.

• Supported healthcare innovation and digital health transformation initiatives.

• Conducted advanced data analysis, reporting and healthcare analytics activities.

• Collaborated with multidisciplinary clinical, operational and engineering teams.

• Acted as a key contact for project teams and study sites, supporting CRF review, query management, and study data review processes.
• Assisted with ethics committee and regulatory authority submissions and notifications.
• Managed ethics committee and regulatory submissions, Trial Master File activities and study tracking systems.
• Acted as a liaison between study sites, sponsors and project teams.
• Contributed to successful delivery of diabetes, infectious disease, vaccine and oncology studies.ls, and systems.

• Supported team effectiveness, workshop planning, and cross-functional coordination within engineering projects.

• Gained expertise in medical technologies through practical application in professional setting.