Purity Bundi

I provided global operational and project leadership for complex early phase oncology development programmes within a pharmaceutical sponsor environment. These programmes include Phase I to IIb clinical trials incorporating first in-human, dose-escalation and dose-expansion designs, requiring close coordination of safety, data, translational and imaging activities. I worked as a core member of global study leadership teams, contributing to strategic planning, risk assessment and delivery against key development milestones. My key responsibilities included:

• Providing programme-level operational oversight across multiple early phase oncology studies, maintaining accountability for timelines, quality, compliance and delivery milestones.

• Lead development and maintenance of integrated study timelines, milestone trackers and operational delivery plans.

• Identify, assess and mitigate operational and regulatory risks, applying proportionate, risk-based decision making aligned with global governance standards.

• Coordinate multidisciplinary internal stakeholders including clinical operations, medical monitors, safety, statistics, data management, imaging, laboratories and translational science teams.

• Lead oversight of external vendors and strategic partners including data management, central laboratories, sample-logistics providers and IMP distribution partners.

• Prepare Interim Analysis and Safety Review Commitee packages in collaboration with statisticians, safety and medical teams.

• Ensure timely supply of IMP and study materials through coordination with internal and external providers.

• Maintain inspection-ready Trial Master Files, ensuring documentation completeness and ongoing quality oversight.

• Support internal audits and regulatory inspections, contributing to responses and corrective and preventative action plans.

• Prepare study update materials, dashboards and presentation packs for internal governance meetings.

Provided senior operational and strategic leadership across the Early Phase and Imaging Research portfolio within Cambridge Clinical Trial Centre. Oversaw delivery of complex oncology, translational and imaging studies sponsored by the Trust and supported by external grant and charitable funding. Operated at portfolio level, supporting departmental leadership and Chief Investigators in planning, governance and sustainable delivery of high-risk clinical research. Acted as a senior decision-maker for trial delivery, exercising regulatory and operational judgement across multiple concurrent studies. Key responsibilities included:

• Lead in operational oversight of a complex early phase oncology and translational research portfolio, ensuring delivery against agreed objectives, timelines and governance standards.

• Providing senior leadership across multiple concurrent studies, balancing competing priorities and directing resource allocation to maintain safe and sustainable delivery.

• Supporting strategic planning of the departmental research portfolio, including feasibility assessment, pipeline development and long-term sustainability planning.

• Acting as a senior interface between Chief Investigators, R&D, finance, pharmacy, laboratories, imaging services and external collaborators.

• Leading preparation and review of study budgets, supporting grant applications and ensuring appropriate stewardship of NHS and charitable research funding.

• Monitoring financial performance across the portfolio, identifying risks to funding or delivery and implementing mitigation strategies.

• Line managing Clinical Trial Coordinators, Data Managers and Clinical Trial Associates, including recruitment, workload allocation, appraisals, performance management and professional development.

• Leading workforce planning to ensure continuity of delivery across high-intensity early phase trials.

As a Clinical Trial Coordinator, I coordinated multiple early phase oncology studies, including multi-centre adaptive Phase I–II trials. These studies involved complex dose-escalation/expansion designs, translational components, imaging

assessments and frequent safety reviews. Alongside daily coordination, I contributed to project planning by tracking milestones, forecasting timelines and identifying operational risks across these studies. My duties and responsibilities include:

• Coordinated end-to-end delivery of CTIMP and non-CTIMP clinical trials from feasibility and study set-up through trial conduct, monitoring, and close-out, ensuring full compliance with ICH GCP, Research Governance frameworks, and the Medicines for Human Use (Clinical Trials) Regulations 2004.

• Led study set-up activities including preparation and submission of IRAS applications, substantial and non-substantial amendments, annual progress reports, and end-of-study documentation to MHRA, HRA, REC, and NHS R&D.

• Maintained complete, accurate, and inspection-ready Trial Master Files (TMF) and Investigator Site Files (ISF), ensuring essential documentation was current and audit compliant at all times.

• Acted as a key liaison with regulatory and ethical authorities, supporting sponsor responsibilities and responding to queries relating to approvals, amendments, safety reporting, and study progress.

• Coordinated multi-site clinical trials, supporting site identification, site set-up, dissemination of approved protocols and amendments, and participation in Site Initiation Visits (SIVs).

• Provided ongoing support and guidance to site research teams, identifying training and resourcing needs to ensure efficient trial delivery and adherence to protocol and GCP

• Manage study-specific finances including invoice processing, expenditure tracking, and liaison with finance teams, ensuring effective use of sponsor and grant funding.