Open to opportunities

Carine Uthayakumar

@carineuthayakumar

Clinical trial operations leader driving Phase I–III study delivery with compliant, data-driven recruitment and multi-site oversight.

United Kingdom

Message

What I'm looking for

I’m looking for a clinical trials operations role where I can lead multi-site delivery, strengthen patient recruitment and data quality, and continuously improve SOPs, governance, and compliance—so studies run on time, within budget, and with confidence.

I’m a Clinical Trial Management professional leading operational delivery across Phase I–III trials in pharmaceutical, biotechnology, and NHS environments. As an Operations Lead for a SaaS clinical research platform, I own end-to-end patient recruitment operations, build data-driven enrolment strategies, and drive recruitment KPIs, forecasts, and resource planning to deliver studies on time, within budget, and in compliance with ICH-GCP.

In my Lead Clinical Research Practitioner role at the University of Oxford (NHS), I lead the ORFAN cardiovascular programme across 10 NHS sites, support NIHR and British Heart Foundation activities, and improve Oxford site recruitment from 55 to 75 participants/month (36% increase). I also support regulatory documentation, TMF/ISF maintenance, monitoring and inspection readiness, resolve 600+ Medidata Rave queries, and contribute to AI cardiovascular research through 1,000+ CT coronary angiography segmentations.

Experience

Work history, roles, and key accomplishments

Current

Lead Clinical Research Practitioner

Current

University of Oxford

Jan 2023 - Present (3 years 6 months)

Led operational delivery of the ORFAN cardiovascular research programme across 10 NHS sites, supporting recruitment, study conduct, governance, and site performance. Supported TMF/ISF maintenance, monitoring, inspection readiness, resolved 600+ Medidata Rave queries, and contributed to AI cardiovascular research via CT coronary angiography segmentations.

Clinical Trial Operations Patient Recruitment Governance Site Performance Monitoring Inspection Readiness AI Research Support

Project Officer

Buckinghamshire Council

Jun 2023 - Dec 2023 (6 months)

Supported delivery of interdisciplinary environmental health research programmes by coordinating stakeholder reporting, academic collaboration, and programme administration. Contributed to the Groundwater Flooding & Mental Health initiative and coordinated engagement across partner organisations, stakeholders, and work packages to support multi-agency delivery and reporting.

Research Collaboration Programme Delivery Reporting

Clinical Trial Management Associate

Gilead Sciences

Sep 2022 - May 2023 (8 months)

Supported delivery of global Phase I immunology trials across the clinical trial lifecycle, including study start-up, site activation, governance, and ongoing study management. Coordinated cross-functional activities, supported CRO/vendor oversight, TMF management, and inspection readiness, including support for PSSVs and SIVs.

Clinical Trial Management Study Start Up Site Activation Clinical Operations Coordination Stakeholder Management CRO Vendor Oversight TMF Management Inspection Readiness Governance Support

Project Support Officer

Buckinghamshire Council

Mar 2022 - Sep 2022 (6 months)

Provided project support for Ukrainian health and research services by coordinating service delivery, stakeholder communication, and operational activities to support continuity of care for displaced populations. Supported multi-agency collaboration and assisted with data tracking, documentation, reporting, and service monitoring.

Project Support Service Coordination Operational Reporting Data Tracking Documentation Monitoring

Laboratory Technician

Feature Medical

Nov 2021 - Mar 2022 (4 months)

Performed high-throughput RT-PCR and LAMP COVID-19 testing workflows, including sample preparation, nucleic acid extraction, assay processing, and quality checks aligned to laboratory SOPs. Maintained sample tracking, result documentation, and data entry to support timely reporting in a fast-paced clinical laboratory environment.

Quality Control Sample Tracking Result Documentation Data Entry

Project Specialist

MedAvante-ProPhase

Jun 2021 - Oct 2021 (4 months)

Coordinated global clinical trial start-up and rater training activities across studies delivered in 10+ countries, supporting investigators and cross-functional teams. Assisted with training coordination, site engagement, and operational communications to support documentation compliance and consistent execution of international clinical trials.

Documentation Compliance Support Site Engagement

Clinical Trial Data Coordinator

Panthera BioPartners

Mar 2021 - Jun 2021 (3 months)

Managed eCRF quality control, sponsor data queries, and clinical trial database updates for Phase III studies. Ensured timely resolution of data queries within 48–72 hours and liaised with CRAs and data management teams to support clean database delivery and analysis readiness.

Sponsor Data Queries Clinical Trial Database Updates Data Query Resolution Data Integrity Data Management