Senior Project Manager - Oncology (AU)

Novotech; Sydney; On-site; AUD 140,000 - 180,000; Full time

Job summary

Novotech is seeking a Senior Project Manager to plan and manage all contracted responsibilities for assigned clinical projects. You will act as the primary contact between Novotech and the client, ensure trials are conducted in accordance with ICH GCP guidelines and local regulatory requirements.

You will oversee project deliverables, lead internal teams and sub-contractors, and monitor the financial performance of the project from site selection through close-out.

Qualifications

• Extensive experience leading clinical trials projects.
• Strong knowledge of ICH GCP and regulatory requirements.
• Proven ability to manage multi-country/vendor projects.

Responsibilities

• Plan and manage contracted responsibilities for assigned clinical projects.
• Act as primary contact between Novotech and client.
• Ensure trials comply with ICH GCP guidelines and local regulations.
• Identify risks and develop risk mitigation plans.
• Mentor junior staff as needed.

Skills

Project management

ICH GCP knowledge

Regulatory compliance

Client communication

Risk management

Job description

The Senior Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned clinical projects. Act as primary contact between Novotech and client. Ensure that clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs and the Project Agreement. Project Manager is responsible for the overall project deliverables, leading the internal team, including sub-contractors and the financial performance of the project.

Senior Project Managers are responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope. The Project Manager is responsible to identify and evaluate potential risks and develop risk management plans to mitigate this risk.

Senior Project Managers (SPMs) are expected to have a sound understanding of the drug development and clinical trial process and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements. SPMs are expected to contribute to process improvement initiatives. SPMs can manage full-service, multi-country and more complex projects including those with multiple vendors.

SPMs may be required to mentor junior staff and are expected to contribute to departmental activities and process improvement initiatives.