1 resumes found

I am a Clinical Biomarker/Biospecimen Operations Manager with over a decade of experience in sponsor/CRO settings. My background combines lab-based scientific training with pre-clinical and clinical operations delivery. I have a strong track record in managing global matrix teams across various regions, focusing on oncology and cardiovascular trials. My expertise includes central-lab set-up, vendor selection, clinical performance KPIs, and ensuring inspection-ready documentation. I am adept at aligning budgets, timelines, risks, and quality to deliver high-quality biomarker data on time. Skills Clinical research team leadership: clear communicator, mentoring, task assignment, and performance management Operational oversight of biospecimen management, sample logistics (sample/data flow), and clinical trial support Regulatory compliance: GCP, ICH Guidelines, SOPs, FDA, EU-CTR Audit & inspection readiness: CAPA implementation, trend analysis, gap assessments Resource and budget management: study-level financial oversight, cost optimisation Cross-functional stakeholder engagement: KOLs, PIs, site staff, Medical Affairs, and Commercial teams Presenting training and development programs for clinical research personnel Strong stakeholder influence Critical reasoning and pragmatic problem-solving Digital workflow integration: eCRFs, operational tracking, performance analytics HA query support Licenses and certifications PPL NO.: SAB: 1551, 2019, Covance CRS Ltd., UK PIL NO.: ENV/19/052, 2019, Covance CRS Ltd., UK Study Director Training, 2018, Envigo CRS Ltd., UK Awards and achievements Hit FPFV milestone earlier than planned under my support in 2 clinical trials (Phase 2 & 3 - IVDR compliance - CE marked kits and assays) Assured earlier completeness of study sample (LPLV) / result (WOC issues) reconciliation supporting fDBL in 2 clinical trials (Phase 3 - 10 years) Initiated a new tracking tool for sample reconciliation, which supported the sponsor’s priority giga trial (Phase 3 - 8300+ patients) iDBL and analysis Finalised 5 QA’d reports a couple of weeks earlier than usual, due to the deep understanding of QA systems and workflow Organised new Lab Set-up till readiness Designed, & implemented a Lab transfer between 2 distant locations and validated and set initiative goals to improve the transferred assays