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Hays Life Sciences
Level 11, Chifley Tower, 2 Chifley Square
Sydney, Australia

Phone: 02 8226 9850
Web Site: http://www.hays.com.au

Company Profile


Clinical Quality and Compliance Manager


col-narrow   

Posted:

07.12.2018

Employment Type:

Full time

Location:

Sydney, NSW 

Title:

Clinical Quality and Compliance Manager

Category:

Clinical Research
col-wide   

Job Description:

Clinical Quality & Compliance oversight job. Perm position home based in Sydney/Melbourne - Biotech company.

Your new company
Hays Life Sciences are working with an exciting Biotechnology company that are expanding rapidly in APAC. With a talented clinical operations team now present in Australia running local and global early phase clinical trials. This is a newly created position to support the expansion of the clinical operations team; the company are looking for a permanent Clinical Quality and Compliance Manager.

Your new role
The Clinical Quality and Compliance Manager will be responsible for overseeing Clinical operations specific CAPAs, supporting internal and external audits and regulatory inspections, acting as the key stakeholder for eTMF for the company, supporting the Clinical team with preparation, conduct and development of responses to health authority inspections of studies and operational activities.

What you'll need to succeed
To succeed in this role you will come from a Clinical Operations background and preferably hold a degree in the Life Sciences. You will have developed proven experience in Clinical quality and compliance oversight and should have assumed a management position specialising in this, with ideally one year management experience in Clinical Quality and six years cumulative clinical operations experience. Major responsibilities will include tracking audit data and training the clinical operations team on key gaps on anticipated risks and critical compliance gaps. You will represent the company for all major internal and external audits and will be responsible for tracking and improving necessary quality data from audit findings, CAPAs etc. You will need to be an excellent communicator who can work well with the clinical operations team to guide and support them in your area of expertise.

What you'll get in return
This is an exciting time to join the company as they expand their trial pipeline in Australia. You will be working in a fast paced environment, surrounded by talented teams of experienced clinical operations professionals. The company have had high praise from employees and engagement levels are very high, with excellent remuneration packages and other benefits on offer.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.



Company Info


Hays Life Sciences
Level 11, Chifley Tower, 2 Chifley Square
Sydney, Australia
Phone: 02 8226 9850
Web Site: http://www.hays.com.au

Clinical Quality and Compliance Manager

col-narrow   

Posted:

07.12.2018

Employment Type:

Full time

Location:

Sydney, NSW 

Title:

Clinical Quality and Compliance Manager

Category:

Clinical Research
col-wide   

Job Description:

Clinical Quality & Compliance oversight job. Perm position home based in Sydney/Melbourne - Biotech company.

Your new company
Hays Life Sciences are working with an exciting Biotechnology company that are expanding rapidly in APAC. With a talented clinical operations team now present in Australia running local and global early phase clinical trials. This is a newly created position to support the expansion of the clinical operations team; the company are looking for a permanent Clinical Quality and Compliance Manager.

Your new role
The Clinical Quality and Compliance Manager will be responsible for overseeing Clinical operations specific CAPAs, supporting internal and external audits and regulatory inspections, acting as the key stakeholder for eTMF for the company, supporting the Clinical team with preparation, conduct and development of responses to health authority inspections of studies and operational activities.

What you'll need to succeed
To succeed in this role you will come from a Clinical Operations background and preferably hold a degree in the Life Sciences. You will have developed proven experience in Clinical quality and compliance oversight and should have assumed a management position specialising in this, with ideally one year management experience in Clinical Quality and six years cumulative clinical operations experience. Major responsibilities will include tracking audit data and training the clinical operations team on key gaps on anticipated risks and critical compliance gaps. You will represent the company for all major internal and external audits and will be responsible for tracking and improving necessary quality data from audit findings, CAPAs etc. You will need to be an excellent communicator who can work well with the clinical operations team to guide and support them in your area of expertise.

What you'll get in return
This is an exciting time to join the company as they expand their trial pipeline in Australia. You will be working in a fast paced environment, surrounded by talented teams of experienced clinical operations professionals. The company have had high praise from employees and engagement levels are very high, with excellent remuneration packages and other benefits on offer.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

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