Harish

About Harish

I am an experienced Clinical Research Professional with over 9 years of experience in the…

Experience

1. Study Start up Lead

   Zenith LifeScience

   Feb 2025 — Present

   Collaborate with global Site Monitoring Leads to ensure alignment on monitoring strategy, timelines, and quality metrics.• Oversee all trial phases: feasibility, site selection, contract/budget negotiation, study start-up, patient enrollment, data collection, and database lock.• Drive strategic trial planning, risk assessment, and resource forecasting in cross-functional meetings.• Maintain alignment between operational execution and strategic study goals, supporting cross-functional teams in a matrixed, global environment.• Act as main point of contact for site staff, investigators, and CRAs, ensuring consistency in communication, documentation, and protocol adherence.• Interface with CMC and regulatory teams to ensure proper handling, tracking, and administration of gene therapy investigational products, including vector storage and shipment compliance.• Facilitate risk-based monitoring and centralized oversight models tailored to rare disease or first-in-human gene therapy populations.• Collaborate with logistics and supply chain teams to coordinate cold chain management and specialty courier services for temperature-sensitive gene therapy products.• Monitor trial performance metrics and KPIs (e.g, enrollment targets, protocol deviations, CRA cycle times), generating dashboards and reports for senior leadership.• Oversee TMF management (eTMF), ensuring document quality, completeness, and audit readiness in accordance with ICH-GCP and company SOPs.• Prepare for and participate in regulatory inspections (FDA, EMA), sponsor audits, and internal QA reviews.• Manage relationships with CROs, central labs, specialty testing vendors, and logistics partners.• Assist in negotiations of budget and contracts with site resolution of issues and contract execution under supervision.