JobCubby JobCubby
Sign up
Novotech Global

Senior Project Manager - Gen Med (CNS)

Novotech Global Sydney, New South Wales, Australia

Biotechnology Research · 1,001-5,000 employees

7 h ago
project-manager Principal (10+ yrs) Full-time Australia
Log in to apply, save this posting, or score it against your profile with AI.

About the role

The Senior Project Manager is responsible for the end-to-end planning and management of clinical projects, ensuring adherence to ICH GCP guidelines and regulatory requirements. They lead internal teams and sub-contractors while managing project deliverables, financial performance, and risk mitigation strategies.

What they look for

Clinical Project Management ICH GCP Clinical Trials Risk Management Drug Development CRO Operations Regulatory Compliance Team Leadership Financial Management Process Improvement Stakeholder Management Site Selection Study Close-out Vendor Management Mentoring

Requirements

Candidates must hold a degree in a clinical or life sciences field and possess at least 8 years of experience in the pharmaceutical industry. A minimum of three years in a project management role is required, with experience in a CRO environment considered advantageous.

Full 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.

Similar roles