Novotech Benefits Overview

Manage end-to-end clinical research projects from feasibility and site selection through study closeout. Lead internal teams, vendors, budgets, timelines, risk mitigation, regulatory submissions, recruitment, site performance, documentation, data management, and pharmacovigilance activities while ensuring compliance with ICH GCP, regulations, SOPs, and client agreements.

Manage standard customer proposals and RFP responses from intake through submission. Coordinate Sales, Pricing, Contracts, and subject-matter experts; assemble compliant content; track timelines, dependencies, and milestones; identify risks; maintain proposal records; and ensure submissions meet quality, accuracy, compliance, and delivery standards. Partner proactively with Sales and stakeholders throughout the proposal lifecycle.

Plans, prepares, reviews, and submits country- and site-level ethics and regulatory authority applications for clinical trial start-up, maintenance, and close-out. Ensures submission packages comply with ICH-GCP, local regulations, SOPs, and project timelines. Coordinates with regulatory start-up managers, project managers, investigative sites, ethics committees, IRBs, and regulatory authorities; tracks submissions and approvals; addresses review comments; and mentors junior staff.