Clinical Quality and Compliance Manager
Clinical Trials Centre
Open to University of Sydney employees only
- Located at Camperdown Campus
- Fixed Term full time for 12 months
- Remuneration Package: $138K, which includes leave loading and up to 17% super
About the opportunity
The Clinical Quality & Compliance Manager directs and supports the CTC’s Quality Assurance and Quality Control Programs and related activities associated with, but not limited to clinical research projects/clinical trials/other CTC research activities. The Clinical Quality and Compliance Manager plans, directs, & coordinates the implementation of CTC’s Quality Assurance and Quality Control program for clinical trials including developing and updating CTC Standard Operating Procedures in accordance with ICH GCP and the applicable regulatory requirements. The CQC Manager has oversight of the ethics and regulatory, onsite and data monitoring, auditing and pharmacovigilance functions, and works cross CTC’s research areas providing expertise and advice on quality and compliance related issues. The CQC Manager demonstrates a capacity for leadership since responsibilities include training team members, evaluating staff performance and leading the resolution of complex issues with the QA and QC Programs.
The University values courage and creativity; openness and engagement; inclusion and diversity; and respect and integrity. As such, we see the importance of recruiting talent aligned to these values and are looking for a Clinical Quality and Compliance Manager who:
- Extensive experience in developing and working on compliance and regulatory affairs in an academic clinical research environment, or similar
- thorough knowledge of GXPs and associated clinical trials regulatory guidelines sufficient to develop and maintain extensive bank of SOP’s for the clinical trials environment.
- previous experience in developing/implementing audit plans and procedures, and ICH GCP audit/training experience.
- knowledge of clinical trial requirements during their lifecycle from start up to close out including a detailed understanding of the regulatory and ethical approval process across Australia
- well-developed project planning, coordination, organisation
- demonstrated ability to prioritize effectively, manage multiple tasks, meet deadlines and achieve required outcomes.
- excellent communication skills and a demonstrated level of tact and discretion in dealing with day to day operational matters.
- high level computing skills with common electronic data capture systems (such as Oracle, Medidata, InForm, etc) Technological proficiency including Microsoft Office suite.
- demonstrated experience in the supervision, training, mentoring and performance management of staff; and experience managing and resolving a diverse range of HR issues.
The NHMRC Clinical Trials Centre, established in 1998, is a fully externally funded research centre. It conducts large multi-centre investigator-initiated clinical trials with national and international collaborators, and contributes expertise and infrastructure for trials run by others. It undertakes research aiming at improving both the conduct of trials and the resulting clinical evidence. The CTC participates in translational research from bench to bedside, conducts methodological research in relation to clinical trials, reviews and synthesises evidence from completed trials and is at the forefront of developments in methods, such as prospective meta-analysis, supervises postgraduate students in all of these areas, offers postgraduate degrees in clinical trials research, runs short courses to train people for Australian medical research, and undertakes health technology and diagnostic test assessments, economic analyses, bio statistical design and analysis, and automated central randomization services. Core funding is provided by the NHMRC, and specific projects are funded by government, public and private institutions and the pharmaceutical industry. The CTC collaborates with, Sydney Catalyst: Translational Cancer Research Centre of Central Sydney and Regional NSW, Australian Clinical Trials Alliance and works with organisations around the world in collaborations that lead to better health outcomes in Australia and internationally. New collaborations are continually sought and then consolidated in research projects.
Since our inception 160 years ago, the University of Sydney has led to improve the world around us. We believe in education for all and that effective leadership makes lives better. These same values are reflected in our approach to diversity and inclusion, and underpin our long-term strategy for growth.We’re Australia's first university and have an outstanding global reputation for academic and research excellence. Across our campuses, we employ over 7600 academic and non-academic staff who support over 60,000 students.
We are undergoing significant transformative change which brings opportunity for innovation, progressive thinking, breaking with convention, challenging the status quo, and improving the world around us.
How to apply
For more information on the position and University, please view the candidate information pack available from the job’s listing on the University of Sydney careers website.
All applications must be submitted via the University of Sydney careers website. Visit sydney.edu.au/recruitment and search by the reference number to apply.
Please note: visa sponsorship is not available for this position
Closing date: 11.30pm, Monday 21 May 2018
The University of Sydney is committed to diversity and social inclusion. Applications from people of culturally and linguistically diverse backgrounds; equity target groups including women, people with disabilities, people who identify as LGBTIQ; and people of Aboriginal and Torres Strait Islander descent, are encouraged.
©The University of Sydney
The University reserves the right not to proceed with any appointment.