Novotech
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Biotech
Manage site relationships and monitor clinical trial conduct to ensure participant safety and data integrity. Perform site initiation, monitoring, and close-out visits (on-site or remote), maintain TMF and CTMS, support regulatory/ethics submissions, drive site recruitment, report study progress, and ensure audit/inspection readiness per ICH GCP and Sponsor/Novotech SOPs.
Biotech
Manage and mentor a team of CRAs, SCRAs, CTAs and administrative staff to ensure clinical trials comply with GCP, SOPs and regulatory requirements. Oversee resourcing, performance management, training, site/vendor relationships, feasibility assessments, and support business development and country/office operations as needed.
Biotech
Lead oversight of multiple early clinical projects and Project/Senior Project Managers, ensuring resource alignment, revenue recognition, change order governance, client account development, and project financial health. Establish account governance, engage senior client stakeholders, support CO negotiations and revenue recovery, collaborate with workforce planning for resourcing and succession, and provide line management, coaching, and performance management for S/PMs to secure phase pull-through and repeat business.
