Jobs at Novotech

Independently manage and monitor assigned clinical trial sites (based QLD/NSW/VIC), ensure participant safety and data integrity, perform SSU including SIVs, drive site performance and recruitment, liaise with investigators, sponsors and internal teams, and apply ICH-GCP to deliver Phase I-III studies.

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.

Conducts clinical trial site monitoring to protect participants, verify source data, and ensure compliance with ICH GCP, regulations, and SOPs. Builds relationships with investigators and site personnel, supports regulatory and ethics submissions, drives participant recruitment, prepares site documents and plans, and performs site selection, initiation, monitoring, close-out, pharmacy, and co-monitoring visits onsite or remotely.

Supports clinical data management projects through clinical trial data entry, validation, reconciliation, query tracking, database and edit-check testing, reporting, and study progress tracking. Assists Clinical Data Managers with data cleaning, external data transfers, coding coordination, meeting documentation, and compliance with GCDMP guidelines, ICH-GCP, regulatory requirements, and standard operating procedures.

Manage full-service, multi-country oncology clinical trials from feasibility and site selection through closeout. Lead cross-functional teams, vendors, sites, and client relationships while ensuring compliance with ICH GCP, regulatory requirements, SOPs, timelines, quality standards, and budgets. Responsibilities include risk management, recruitment oversight, regulatory submissions, safety coordination, data management, investigational product logistics, audit readiness, financial forecasting, team mentoring, and process improvement.

Independently monitors clinical trial sites, supports patient recruitment, builds investigator and site relationships, partners with sponsors and internal teams, and ensures participant safety, regulatory compliance, trial quality, and data integrity across early- and late-phase studies.

Develop operational strategies for oncology clinical trial opportunities, translating sponsor requirements, feasibility data, and operational insights into study execution plans, proposal content, budgets, and risk mitigation recommendations. Lead operational input during sponsor meetings and bid defenses, collaborate across Business Development, Finance, Clinical Operations, and other functions, and support handoff of awarded studies to delivery teams. Improve proposal methodologies, documentation, analytical processes, and cross-functional alignment.

Manages clinical research projects from site selection through study closeout, overseeing timelines, budgets, risks, vendors, sites, recruitment, regulatory submissions, data management, safety activities, and essential documentation. Serves as the primary client contact, leads internal teams, ensures compliance with ICH GCP and applicable regulations, manages project profitability, supports feasibility and business development activities, and contributes to process improvement.

Leads regional transformation initiatives across a clinical research organization, managing project plans, budgets, resources, governance, risks, dependencies, vendors, testing, data migration, communications, training, and stakeholder adoption. Partners with CRO teams, IT, and leadership to standardize processes, improve operational efficiency, implement systems, and ensure projects align with business objectives. Reports progress to steering committees and supports change management, benefits realization, and governance activities.