Rajeev Kumar
Clinical Trial Professional
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About
A dedicated Clinical Trial professional with 12+ years of experience. Having built a self-sustaining retail business, I am now refocusing my career on my core passion for clinical research. I bring enhanced skills in problem solving and conflict resolution, and I am a proactive, flexible, and easy-to-work-with individual. With a pragmatic approach, I am eager to re-apply my deep expertise in Clinical Trials operations to improve patient lives and advance human health.
Experience
Operations Director - Commercial Postal & Retail Operations - London, UK
(2024-06)
- Delivered high-quality customer service, maintaining a reputation for reliability and trust within the community.
- Expertly handled complex customer complaints with a calm, professional, and solution-oriented approach.
- Recruited, trained, and managed a team to deliver consistent service standards.
- Acted as a trusted advisor to the public, ensuring accessible service delivery.
Clinical Research Associate - Abbott Laboratories
(2023-08 - 2024-06)
Abbott Laboratories – Multinational Healthcare and Medical Devices Company
- Monitor FreeStyle Libre trials in compliance with ISO 14155 and MDR standards.
- Perform high-standard SDV and SDR to ensure clinical data accuracy and integrity.
- Manage sites from start-up to close-out (SIV to COV) ensuring top quality.
- Resolve complex site issues and recruitment bottlenecks with a pragmatic approach.
- Audit site documentation and CRFs to meet strict ALCOA+ and regulatory standards.
- Identify compliance risks and implement CAPAs to protect study timelines and safety.
- Collaborate with cross-functional teams to drive study success and deliverables.
- Maintain TMF and ISF documentation to a gold standard, inspection-ready level.
- Report Adverse Events (AEs/ADEs) to ensure patient safety and ethical compliance.
Quality Operations Manager - hVIVO services Ltd - UK
(2022-05 - 2023-05)
hvivoservices Ltd - Leading Clinical Research Organisation, UK
- Played a key role in the successful MHRA inspection.
- Quality Control of TMF prior to archiving, as per regulatory expectations.
- Provided continuous support for CAPA completion by conducting Root Cause Analysis and effectiveness review.
- Monitored GCP compliance by maintaining and actioning key matrices and challenging poor practice.
- Maintained high standards by reviewing and approving SOPs, Quality Policies, Regulatory Positions and Master forms.
- Owned system (eQMS & eArchive) presented as an ideal example of a validated system for MHRA inspection.
- Lead Various projects by building good relationships with different departments for successful delivery.
Clinical Training & Education Manager - Richmond Pharmacology Ltd
(2012-12 - 2022-04)
- Ensured staff adhered with ICH-GCP guidelines, study specific training and competencies in order to execute their role across various Phase 1, 2 & 3 studies.
- Led a newly established department focussed on improving clinical training structures
- Challenged and mitigated poor clinical practices, managed GCP training for staff and resolved CAPA related issues
- Audited staff to validate compliance with clinical study protocols and to improve training compliance.
- Identified areas of improvement related to clinical Trials quality, across multiple departments.
Clinical Quality Manager - Richmond Pharmacology Ltd
(2012-12 - 2022-04)
- Ensured adherence with SOPs and GCP guidelines
- Planned, prepared and conducted clinical trials for various therapeutic areas
- Responsible for managing clinical activities on the weekends, taking high level actions where necessary.
- Oversight of staff compliance of protocol mandated clinical procedures and schedule of assessments.
- Supervised complex studies and ensured alignment with core study primary objectives and goals
Laboratory Manager - Richmond Pharmacology Ltd
(2012-12 - 2022-04)
- Maintained a smooth lab operation and managed samples from different clinical trials
- Maintained the laboratory to inspection readiness standards by adhering to SOPs and ICH-GCP guidelines
- Utilised a Sample Tracking system, created to improve sample tracking across various stages of the trial.
- Ensured the maintenance and smooth operation of all laboratory equipment, and the stock levels.
- Collaborated with other departments and external laboratories to coordinate clinical trial operations, sample shipment, storage, and processing
- Developed a sustainable new team and maintained high standards.
Clinical Trial Assistant - Richmond Pharmacology Ltd
(2012-12 - 2022-04)
- Conducted clinical trial procedures and ensured adherence with protocol and health and safety standards.
- Processed samples including blood, urine, and other biological samples as per study protocol,
- Supported the quality assurance departments by preparing for audits and inspections.
Education
MSc - Pharmaceutical Science - University of Greenwich (2012)
Bachelor's degree - pharmacy - Rajasthan University of Health Science (2006 - 2010)
