Gavri Luhar
Associate Clinical Operations Leader
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About
Clinical trial operations professional with 11+ years' experience delivering global clinical trials across Phases I–IV.
Currently Associate Clinical Operations
Leader on two global oncology studies, with proven expertise in end to end trial delivery, cross functional leadership, and operational strategy. Strong background in oncology and haematology with a consistent record of delivering on time, to quality, and within scope. PRINCE2 certified with in depth knowledge of ICHGCP, MHRA, FDA, and EMA requirements.
Experience
Associate Clinical Operations Leader at Jazz Pharmaceuticals (via Parexel FSP) (2025-12 – Present)
- Support two global Phase II oncology trials with responsibilities for delivery from feasibility through closeout
- Drive study timelines, risk management, and performance metrics (enrolment, data quality, protocol deviations)
- Develop and implement country and site level strategies to optimise recruitment and retention
- Oversee vendors and CROs to ensure delivery against KPIs, contracts, and budgets
- Ensure inspection readiness through oversight of eTMF, CTMS, and study documentation
- Coordinate cross functional teams to ensure seamless alignment and delivery across clinical, regulatory, and operational work streams
- Support trial leadership through close collaboration with the Clinical Trial Manager and direct reporting to the Clinical Trial Director on study progress, risks, and strategic priorities
Lead UK Clinical Research Associate at Parexel (2024-10 – 2025-11)
Country level CRA operational lead for global Phase III vaccine trial
- Country level CRA operational lead for global Phase III vaccine trial
- Managed UK delivery including CRA oversight, site performance, and enrolment targets
- Led risk assessment, monitoring strategy, and mitigation planning
- Reported study progress to senior stakeholders and global teams
- Contributed to exceeding recruitment targets and supporting interim analysis/DSMB milestones
- Coached and developed CRAs to ensure consistent quality and compliance
Senior Clinical Research Associate at Parexel (2022-05 – 2024-10)
Led site feasibility, selection, and monitoring activities across UK studies
- Led site feasibility, selection, and monitoring activities across UK studies
- Supported resource planning and operational delivery strategies
- Developed training materials and mentored and trained CRAs
- Recognised by sponsor as preferred Lead CRA based on performance
Clinical Research Associate II at Parexel (2021-06 – 2022-04)
Independently managed monitoring activities for oncology and hepatology trials
- Independently managed monitoring activities for oncology and hepatology trials
- Ensured protocol compliance and high quality data delivery across sites
Clinical Research Associate at IQVIA Biotech (2020-03 – 2021-06)
Delivered end to end monitoring for oncology/haematology trials
- Delivered end to end monitoring for oncology/haematology trials
- Awarded EU Rookie of the Year (2020) within 6 months of joining the team
- Supported critical COVID19 clinical trial activities
Clinical Trials Monitor at Queen Mary University London (2018-07 – 2020-03)
Led monitoring for multi country EU trials
- Led monitoring for multi country EU trials (25+ sites)
- Managed regulatory submissions and reporting to oversight committees
- Establish monitoring guidelines and present monitoring outcomes and study updates to the Chief Investigator
Clinical Trials Practitioner / Coordinator at Guy's & St Thomas' NHS FT (2015-11 – 2018-07)
Managed trial coordination and patient caseloads in haematology
- Managed trial coordination and patient caseloads in haematology
- Supported feasibility, submissions, and mentoring of junior staff
- Execute protocol required procedures, including patient assessments, phlebotomy, sample processing and logistics, and management of study data and queries
Clinical Trials Staff at Great Ormond Street Hospital (2013 – 2015)
Early career experience
Special Constable at Thames Valley Police (2016 – 2019)
Early career experience
Education
BSc in Biomedical Science (Biochemistry) – Brunel University London (2013)
PRINCE2 Practitioner; 2019
