Bioagilytix20h ago

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Study Manager (Biology)

Australia·MelbourneFTmid

OtherManager

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Overview

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation.

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OtherManager

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.

To provide leadership and management of studies within 360biolabs’ Clinical Group ensuring that the group supports PK & PD endpoints for clinical trials and preclinical studies as part of an integrated service adhering to industry best practice and all relevant regulatory guidelines.

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.

Technical

Assist in the coordination and conduct of method development, optimisation and validation of PK & PD assays, including immunoassays for use in human and animal studies

Assist in the design, management and troubleshooting assays for preclinical studies and clinical trials

Project Management

Work as part of the Clinical team to execute start-up activities associated with the implementation of new clinical studies

Proactively manage relationships between internal resources and external entities such as vendors, clients and partner organisations

Liaise with colleagues and client representatives to ensure study activities are delivered consistent with Work Order timelines

Represent the company and the Clinical Group in interactions with clients from initial technical discussions through study initiation, execution and reporting

Fulfill the role of Study Director as required

Data analysis and Reporting

Maintain reports and records to levels consistent with relevant standards

Perform data analysis and data integrity reviews and provide clear interpretation of data to others

Produce and review reports and presentations for internal use and communication to clients and external bodies

Sign Off & Approval Authority

Validation and Analytical Plans, Protocols and Reports

SOPs and Proformas

Purchasing (subject to approval limits)

Leadership

Provide leadership and drive the work ethic and culture of the Scientific Operations group

Management of staff including managing priorities, supervision, training and development

Quality & Accreditation

Adhere to ISO/IEC 17025, the OECD Principles of Good Laboratory practice, 360biolabs’ Quality Management System, SOPs, and other requirements as per NATA Accreditation and regulatory guidelines

Maintain awareness of, and ensure compliance with, relevant International Standards and Guidelines including ICH GCP

Safety

Ensure the safe and efficient conduct of company activities

Team Work

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

Professional Development

Attend and actively participate in company meetings including project and client management, departmental and laboratory meetings where appropriate

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

BSc in a Biological discipline (Essential)

PhD or equivalent experience plus research or industry leadership (Essential)

Experience in laboratory techniques, pharmacokinetic and pharmacodynamic assays (Essential)

Experience in method development and validation of immunology assays including cytokine analyses and ELISA (Desirable)

Experience in the conduct of clinical studies and in the processing and analysis of preclinical and clinical samples (Essential)

Excellent organisational and report writing skills (Essential)

Ability to work effectively as part of a team (Essential)

Excellent analytical, interpersonal, verbal and written communication skills (Essential)

Experience with database computer software and file management (Essential)

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

High motivation and enthusiasm for medical research, drug and vaccine development (Essential)

Applications close on 29th June 2026 at 9:15AM, but may close earlier if a large number of applications are received. For further information, please contact our Careers Team (careers@360biolabs.com). Please submit your application via the job link if you're interested in joining us, as we’re not able to process applications sent by email.

Apply now if you have what it takes to join our team!

360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability.

To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights.

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