Novotech is seeking an experienced Project Manager to lead the global clinical trial lifecycle from feasibility and site selection through study close-out. The Project Manager will be the primary point of contact for sponsors, responsible for planning, execution and management of all contracted project responsibilities to ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, applicable regulatory requirements and Novotech SOPs. You will lead cross-functional teams across Clinical Operations, Regulatory Affairs, Medical, Biostatistics/Data Management, Pharmacovigilance and Vendor Management; oversee start-up activities; monitor budgets and timelines; manage risks and issue mitigation; and maintain strong sponsor relationships throughout the project lifecycle. Responsibilities include development and maintenance of project plans, risk registers, study timelines and CTMS; vendor selection and oversight; site identification and activation; ethics and regulatory submissions; site training; recruitment management; monitoring and issue resolution; data quality and safety coordination; and audit/inspection readiness. You will also support continuous improvement, feasibility assessments, and business development activities as appropriate. This is a remote opportunity based in the United Kingdom (City of London area).
Novotech is seeking an experienced Project Manager to lead the global clinical trial lifecycle from feasibility and site selection through study close-out. The Project Manager will be the primary point of contact for sponsors, responsible for planning, execution and management of all contracted project responsibilities to ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, applicable regulatory requirements and Novotech SOPs. You will lead cross-functional teams across Clinical Operations, Regulatory Affairs, Medical, Biostatistics/Data Management, Pharmacovigilance and Vendor Management; oversee start-up activities; monitor budgets and timelines; manage risks and issue mitigation; and maintain strong sponsor relationships throughout the project lifecycle. Responsibilities include development and maintenance of project plans, risk registers, study timelines and CTMS; vendor selection and oversight; site identification and activation; ethics and regulatory submissions; site training; recruitment management; monitoring and issue resolution; data quality and safety coordination; and audit/inspection readiness. You will also support continuous improvement, feasibility assessments, and business development activities as appropriate. This is a remote opportunity based in the United Kingdom (City of London area).
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