Quality Manager- Clinical Trials
5 months ago
**About the Company**
Our client provides a range of pathology testing services to global clinical research organisations (CRO’s) to support Phase I to Phase IV clinical trials. Their parent company is one of the largest pathology firms in Australia. They have state-of-the-art purpose-built laboratories in Victoria and Queensland. The scope of testing includes Haematology, Chemical Pathology, Microbiology, Serology, Histology and other speciality testing services.
**The Role**
The role will provide Quality & Risk Management to two Clinical Laboratories (Melbourne & Brisbane) as a dedicated Histology Laboratory (Sydney). This is a national role and you will be supported by a team of 6 other quality managers working across various other business units Australia wide. Supportive and inclusive team environment.
Your duties will include:
**Clinical Trials Laboratory**:
- Establish and implement processes for identifying and assessing quality risks in clinical trials protocols, sample processing, analysis and storage, data collection, administration and general trial conduct, ensuring adherence to GCP and GCLP standards.
- Conduct internal audits.
- Facilitate regulatory inspections and external audits and support the preparation of responses to inspection findings.
- Represent ACL Clinical Trials in sponsor external audits and provide guidance to clinical trials staff for regulatory audit response.
- Develop and maintain quality management systems for clinical trials, including SOPs, work instructions, and templates, with a specific focus on GCP and GCLP requirements.
- Provide training and support to staff on quality-related topics and procedures.
**Histology Laboratory**:
- Ensure the Histology laboratories meet relevant certification and accreditation standards, which may include but not be limited to ISO 15189, ISO 17025, and NPAAC requirements.
- Conduct internal audits.
- Facilitate regulatory inspections and external audits and support the preparation of responses to inspection findings.
- Monitor NATA accreditation outcomes and completion of actions within the required timeframes in conjunction with the laboratory managers.
- Develop and maintain quality management systems, including SOPs, work instructions, and templates, with a specific focus on ISO 15189, ISO 17025, and NPAAC requirements.
**About you**:
To be considered for this role your skills and attributes should include:
- Bachelor’ Degree in Medical Science of equivalent
- Experience in regulatory inspections and audit procedures related to GCP/GCLP, NATA, ISO 15189, ISO 17025 and NPAAC standards.
- Strong knowledge of clinical trial processes, protocols, and data management, with a specific focus on GCP and GCLP requirements.
- High level of interpersonal and communication skills
- Excellent organisational skills with an ability to work independently.
**This is a Hybrid role, with flexibility to work from home 2 to 3 days a week. You will be required to travel to QLD/NSW bi-monthly.**
For more information about this role, please contact
-
Clinical Trials Coordinator
3 weeks ago
Melbourne, Victoria, Australia Melanoma and Skin Cancer Trials (MASC Trials) Full timeJob SummaryThe Melanoma and Skin Cancer Trials (MASC Trials) is seeking a highly organized and detail-oriented Clinical Trials Assistant to provide operational support to the team. The successful candidate will be responsible for ensuring effective collaboration and teamwork in the clinical trial setting, as well as contributing to the broader aims of MASC...
-
Clinical Trials Project Manager
3 weeks ago
Melbourne, Victoria, Australia Avance Clinical Pty Full timeJob Title: Clinical Trials Project ManagerAbout the Role:Avance Clinical Pty is seeking an experienced Clinical Trials Project Manager to join our team. As a Clinical Trials Project Manager, you will be responsible for managing clinical projects from commencement to completion, ensuring timely and budget-friendly delivery. You will be the interface between...
-
Clinical Trial Associate I
5 months ago
Melbourne, Australia Avance Clinical Full time**Who are we?** We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our...
-
Clinical Trial Manager
2 months ago
Melbourne, Victoria, Australia Bancroft School Full timeJob DescriptionBancroft School is seeking a highly skilled and motivated Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for managing clinical trials from start to finish, ensuring that all aspects of the trial are conducted in accordance with regulatory requirements and industry standards.Key...
-
Clinical Trial Manager
3 weeks ago
Melbourne, Victoria, Australia Pharmiweb Full timeClinical Trial Manager Job DescriptionAs a Clinical Trial Manager at Pharmiweb, you will be responsible for the day-to-day management and oversight of assigned clinical trials to ensure deliverables are met in all phases of the trial. You will lead the Clinical Trial Team and support other development teams as a Clinical Operations representative as...
-
Clinical Trials Manager
1 hour ago
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeCompany OverviewWe are a pioneering clinical research organization dedicated to advancing medical science through innovative trials. Our team is focused on fostering collaborations that drive breakthroughs in healthcare, and we pride ourselves on creating a culture that prioritizes integrity, quality, and patient welfare.About the OpportunityThis role offers...
-
Clinical Trial Manager II
4 weeks ago
Melbourne, Victoria, Australia Pharmiweb Full timeJob Title: Clinical Trial Manager IIAs a Clinical Trial Manager II, you will be part of a dynamic team responsible for managing clinical trials from start to finish. Your primary focus will be on ensuring the successful execution of clinical trials, meeting quality and regulatory requirements, and delivering high-quality data to our clients.Key...
-
Clinical Trials Manager
1 month ago
Melbourne, Victoria, Australia Allucent Full timeJob Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...
-
Clinical Trials Manager
3 weeks ago
Melbourne, Victoria, Australia Allucent Full timeJob Title: Clinical Trials ManagerWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to the Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.Key...
-
Clinical Trials Pharmacist
4 weeks ago
Melbourne, Victoria, Australia St Vincent's Hospital Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Pharmacist to join our team at St Vincent's Hospital Melbourne. As a key member of our pharmacy department, you will play a critical role in managing clinical trials and investigational medicines used at our hospital.Key Responsibilities:Manage clinical trials and investigational...
-
Clinical Trials Pharmacist
1 month ago
Melbourne, Victoria, Australia St Vincent's Hospital Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Pharmacist to join our team at St Vincent's Hospital Melbourne. As a key member of our pharmacy department, you will play a critical role in managing clinical trials and investigational medicines used at our hospital.Key Responsibilities:Manage clinical trials and investigational...
-
Clinical Trials Pharmacist
4 weeks ago
Melbourne, Victoria, Australia St Vincent's Hospital Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Pharmacist to join our team at St Vincent's Hospital Melbourne. As a key member of our pharmacy department, you will be responsible for managing clinical trials and investigational medicines, including dispensing, drug accountability, and preparation.Key Responsibilities:Manage...
-
Clinical Trial Manager UK
3 weeks ago
Melbourne, Australia Pharmiweb Full timeClinical Trial Manager - Sponsor Dedicated ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Trial Manager to...
-
Clinical Trials Coordinator
1 month ago
Melbourne, Victoria, Australia Healthcare Professionals Group Full time{"title": "Clinical Trials Coordinator", "description": "About the OpportunityWe are seeking a highly skilled Clinical Trials Coordinator to join our dynamic team of clinical specialists. In this pivotal role, you will be at the forefront of managing clinical trials, ensuring that each study is conducted with precision and care. Your expertise will help...
-
Clinical Trials Coordinator
3 weeks ago
Melbourne, Victoria, Australia Alfred Health Full timeAbout the RoleMASC Trials is seeking a highly organized and detail-oriented Clinical Trials Assistant to provide operational support to the team. The successful candidate will be responsible for ensuring effective collaboration and teamwork in the clinical trial setting, as well as contributing to the broader aims of MASC Trials.Key ResponsibilitiesProvide...
-
Clinical Trials Manager
5 months ago
Melbourne, Australia The Royal Children's Hospital Full timeLocation: Melbourne | Parkville Job type: Full Time - Fixed Term Organisation: The Royal Children's Hospital **Salary**: $118,000 - $131,000 Occupation: Health and Allied Health Reference: 11595 **The Role**: An exciting opportunity exists for an experienced people leader to join the team at the Children's Cancer Centre (CCC) as the Clinical Trials...
-
Clinical Trials Assistant
3 weeks ago
Melbourne, Australia Alfred Health Full timeAlfred HealthAlfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services. Fixed Term – 12 month contract – with possibility to extendFull-time: 76 hours...
-
Clinical Trials Consultant
5 days ago
Melbourne, Victoria, Australia Boehunter Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Officer to join our client's team in a Clinical Trials Consultant role.As a key member of the team, you will be responsible for providing top-tier medical care to participants in ongoing clinical trials.Deliver high-quality medical services to clinical trial participants, following trial protocols,...
-
Clinical Trials Manager
5 months ago
Melbourne, Australia Gilead Sciences Full timeFor Current Gilead Employees and Contractors: At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. **Job...
-
Clinical Trial Team Leader
5 months ago
Melbourne, Australia Austin Health Full timeLocation: Melbourne | Northern Metropolitan Job type: Full time, Part time Organisation: Austin Health **Salary**: Salary not specified Occupation: Administration/Secretarial, Human Resources, Legal, Occupational Health and Safety, Medical, Nursing Reference: 50169 An exciting opportunity exists for a Clinical Trial Team Leader position to join Austin...
