Jobs at Novotech

Lead and manage clinical trial projects end-to-end, ensuring compliance with ICH GCP and local regulations. Oversee budgets, timelines, vendors, site selection and activation, recruitment, eTMF/CTMS maintenance, safety and data coordination, and client communications to deliver projects on time and on budget.

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.

Conduct independent site monitoring for biotech and pharmaceutical clinical trials across Phase I–III studies. Build partnerships with investigators and site teams, support patient recruitment and site performance, collaborate with sponsors and internal teams, and ensure participant safety, regulatory compliance, and clinical data quality. CRA II applicants need at least six months of independent monitoring experience; CRA III applicants need at least two years.

Lead end-to-end clinical trial delivery including planning, site selection, vendor management, team leadership, budget and revenue management, risk mitigation, regulatory and ICH GCP compliance, eTMF/CTMS oversight, recruitment monitoring, client liaison, and audit/inspection readiness.

Leads full-service, multi-country clinical trials from feasibility and site selection through closeout. Manages cross-functional teams, vendors, budgets, timelines, risks, regulatory and ethics submissions, recruitment, data and safety activities, trial documentation, investigational product logistics, audit readiness, and sponsor communications. Provides oversight, ensures ICH GCP and regulatory compliance, supports process improvements, and mentors junior staff.

Conduct pharmacovigilance activities for clinical research projects, including safety database preparation, case processing, safety narratives, regulatory submissions, expedited and periodic reporting, reconciliation, audit support, and corrective actions. The role coordinates with medical monitors, clients, investigators, and study teams; provides safety training; maintains trial documentation; and ensures submissions comply with international drug-safety regulations and project 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.

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.

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.

Manage site relationships and monitor clinical trials to ensure participant safety and accurate data. Perform site initiation, monitoring, and close-out visits (onsite or remote), support regulatory and ethics submissions, prepare essential documents, drive site recruitment, and ensure compliance with ICH GCP, local regulations, and Sponsor/Novotech SOPs.

Lead clinical systems, reporting and AI/automation initiatives for clinical operations. Manage end-to-end project delivery, stakeholder governance, KPI/reporting definition (Power BI/Excel), and drive adoption, compliance and process improvements across Veeva/Obvio and eClinical platforms.

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.

Manage and monitor assigned clinical trial sites independently; ensure participant safety, data quality and regulatory compliance; build investigator/site relationships; drive site performance and recruitment; partner with sponsors and internal teams to deliver Phase I-III studies.