360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.

Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.

The purpose of this role is to assist in the management of clinical projects supported by 360biolabs. Responsible for clinical study associated documentation to support the conduct of high-quality collaborative R&D at 360biolabs for clients to under the requirements of the company’s NATA accreditation, regulatory requirements and SOP requirements.

Key Responsibility Areas

The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the position activities.

Clinical Project Management

Assist in the planning and start-up activities associated with the implementation of new clinical studies

Draft and review reports related to laboratory manuals, analytical plans and study reports

Coordinate the supply and management of sample collection supplies to clinical sites per the study laboratory manual

Liaise and coordinate with clients to ensure activities are aligned to deliver goals

Provide project management support to clinical project teams

Work with colleagues and management to monitor clinical study timelines and budgets

Communicate clearly, professionally, and proactively to manage expectations, resolve issues, and ensure alignment across all stakeholders

Contribute to clinical project and team meetings as appropriate to aid with project tracking and reporting

Coordinate and actively participate in company meetings including project and client management

Data Analysis, Reporting, and Document Work

Compile and review reports on clinical activities, timelines and outcomes

Maintain records to levels consistent with relevant standards

Assist in the production of both internal reports and reports for clients

Client Interactions

Participate in and actively contribute to technical and logistical discussions with clients

Organise and oversee activities required to achieve client deliverable timelines for multiple projects and clients

NATA Accreditation

Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as per NATA Accreditation and regulatory guidelines.

Teamwork

Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners.

Professional Development

Attend meetings associated with clinical research and the work of 360biolabs.

Participate in professional activities including attendance at training courses and seminars in the field of expertise.

Key Selection Criteria

Bachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)

Experience / Knowledge / Attributes

Experience in medical laboratory techniques (Essential)

Excellent organisational and writing skills (Essential)

Ability to work as part of a team (Essential)

Good communication skills (Essential)

Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)

Experience with database software and file management (Essential)

Experience in the conduct of clinical trials (Essential)

High motivation and enthusiasm for medical research and drug development (Desirable)

Project Manager

About this role

Key Responsibility Areas

Key Selection Criteria

Experience / Knowledge / Attributes

Explore related jobs

More jobs at Bioagilytix

Jobs in Melbourne

Browse these categories