Novotech
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Biotech
Lead and manage delivery of finance-related projects and migrations using standardized PM methodologies. Oversee planning, resourcing, risk and benefits realization, stakeholder engagement, data migration, system configuration, vendor management, governance, and adoption across global teams.
Biotech
Plan, prepare, and review country- and site-level ethics and regulatory authority submissions during clinical trial start-up and maintenance, ensuring compliance with ICH-GCP and local regulations. Act as primary contact for start-up managers, provide regulatory guidance, develop ICFs and study-specific documents, track submission timelines, contribute to process improvements, and mentor junior RSAs.
Biotech
Provide in-house support for clinical trials including document development and management, TMF and CTMS oversight, site file preparation, trial material logistics, QC reviews, and assisting CRAs with monitoring visit preparation and follow-up according to ICH GCP and company SOPs.
