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Biotech
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.
Biotech
Support start-up phase of clinical trials by preparing, submitting, and tracking country- and site-level ethics and regulatory authority applications per ICH-GCP and local requirements. Act as contact for sites, manage submission timelines, respond to reviewer queries, and advise project leads on local regulations to enable timely approvals.
Biotech
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.
Biotech
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.
Biotech
Independently manage and monitor assigned clinical trial sites to ensure participant safety, data integrity and regulatory compliance (ICH-GCP). Build strong relationships with investigators and site staff, drive site performance and patient recruitment, and partner with sponsors and internal start-up and regulatory teams to deliver clinical trials.
Biotech
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.
Biotech
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.
Biotech
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.
