3 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

I am a highly motivated Cardiac Physiologist with over 30 years of experience in both non-invasive and invasive cardiac investigations. I have been BSE accredited since 2007 in adult transthoracic echocardiography and possess specialist skills in echocardiography. I am adept at performing and reporting scans to BSE standards on various ultrasound equipment, including GE and Philips, and am familiar with numerous reporting systems. Skills Transthoracic echocardiography TOE assistance ECG and Echo teaching Resus coordination Staff management ETT and Tape Analysis Holter monitor hook-up and analysis ECG analysis Licenses and certifications BSE Accreditation in Adult Transthoracic Echocardiography (2007) Immediate Life Support Certified Corporate and Clinical mandatory training Awards and achievements

I am a dedicated and detail-oriented data analyst with a strong foundation in computer science. I am eager to apply my analytical skills and knowledge in a professional setting to drive business growth. I have experience in data visualization and analysis, and I am committed to delivering data-driven solutions that meet business needs. Skills Programming languages: SQL Data analysis and visualization tools: MS Excel (pivot tables, charts, dashboards) Operating Systems: Windows Strong understanding of statistical concepts and data modeling Strong analytical and problem-solving skills Effective communication and presentation skills Ability to work independently and collaboratively as part of a team Strong attention to detail and organizational skills Licenses and certifications Data visualization internship Awards and achievements