Study Manager

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.

Provide leadership and management of studies within 360biolabs' Bioanalytical Group ensuring that the group supports PK and other endpoints for clinical trials and preclinical studies as part of an integrated service adhering to industry best practice and all relevant regulatory guidelines.

**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.

**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

**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

**Technical**
- Take a leading role in the coordination of method development, optimisation and validation of analytical methods and assays, including LCMS, LCMS/MS, Q-TOF MS and HPLC for use in human and animal studies.
- Assist in the design, management and troubleshooting assays for preclinical studies and clinical trials

**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

**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 Principle Investigator as required

**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

**Sign Off & Approval Authority**
- Validation and Analytical Plans, Protocols and Reports
- SOPs and Forms

**Key Selection Criteria**:

- BSc in a chemistry / biochemical discipline (Essential)
- PhD or equivalent experience plus research or industry leadership (Essential)

**Experience/ Knowledge/ Attributes**:

- Experience in laboratory techniques, pharmacokinetic and pharmacodynamic assays (Essential)
- Experience in method development and validation of LCMS/MS PK assays and/or QTOF MS metabolite identification research (Desirable)
- Experience in the conduct of clinical studies and in the processing and analysis of preclinical and clinical samples (Desirable)
- 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)

Benefits of working with 360biolabs include working with the best people (and technology) in our field, local and global career opportunities and a genuine focus on wellbeing and connection., In addition, competitive remuneration packages will be offered to successful applicants based on skills and experience.

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.