Quality Manager, Clinical Trials

the original; Sydney; On-site; AUD 134,000 - 160,000; Full time

Job summary

The Lead Research Quality, Safety and Governance role sits within the Northern Sydney Local Health District's Research Directorate. Based at Kolling/RSNH, the position leads safety and quality across research services and supports clinical trial units, audits and governance programs.

The role requires tertiary qualifications in health or business, strong knowledge of NSQHS and GCP, and proven experience in quality improvement and data management within a large health system.

Qualifications

• Tertiary qualifications in applicable related field including health or business, and/or demonstrated relevant work experience.
• Extensive experience with NSQHS Standards and accreditation processes; training staff in Good Clinical Research Practice and related guidelines (ICH-GCP, TGA CTN, US FDA knowledge).
• Experience in quality improvement methodologies, risk management, data management for research and data extraction/collection.

Responsibilities

• Lead safety and quality functions with assurance on standards of research services across NSLHD.
• Support research teams and clinical trial units; lead quality initiatives and audits; report to Research Executives.

Skills

Quality leadership

Communication skills

GCP familiarity

Education

Tertiary qualifications in health or business

Job description

Lead Research Quality, Safety and Governance Across One of NSW's Leading Health Districts

Employment Type

TemporaryFull Time until 14 September 2028 (with possibility of ongoing employment)

Position Classification

Health Manager Level 4

Remuneration

$2,942.95 - $3,506.31per week

Hours Per Week

38

Requisition ID

REQ699959

Who we are

We are a health service that touches thousands of lives across the Northern Sydney Local Health District, together as a team of like-minded people. We are passionate, driven and have the skills and knowledge to care for our patients whilst creating the best services possible. Our teams have meaningful, interesting and rewarding work everyday. We challenge and nurture each other, sharing our knowledge and experience so that we can deliver better care for everyone There's a real sense of belonging here because we value and respect our patients, employees, and teams' voices. You'll feel a real privilege being a trusted caregiver in our patients, their families, their carers, and our communities' lives.

NSLHD is proud of our diverse and inclusive workplaces, a place where health care professionals can thrive and feel they belong. We are committed to ensure that all our people feel respected and participate safely within a work environment without aggression, sexual harassment, discrimination and racism.

Where you'll be working

Based at the Kolling, RNSH in the Research Directorate

What you'll be doing

The Quality Manager will lead the safety and quality functions with assurance on standards of research services across NSLHD. This includes facilitation and support to Research teams, clinical trial units and lead quality initiatives, risk management, measuring improvement through audit and reporting to Research Executives. The role also participates in incident review, complaint handling, Risk Management, Policy & Procedure development as well as maintenance of the Research Communication, guidance through Sharepoint.

People of Aboriginal and/or Torres Strait Islander background are encouraged to apply.

Candidates will need to meet the following criteria:

• Tertiary qualifications in applicable related including either health or business qualifications and/or demonstrated relevant work experience.
• Highly developed understanding and extensive experience in applying the National Clinical Trials Governance Framework, National Safety and Quality Health Service (NSQHS) Standards and accreditation processes, training staff in Good Clinical Research Practice, regulatory, ethical, privacy and other relevant guidelines processes or procedures relating to research pharmacovigilance including ICH-GCP, TGA CTN, knowledge of US FDA and DHHS, ISO14155 (devices) standards and guidelines.

Demonstrated experience in quality improvement methodologies and risk management processes, data management for research and research related activity, including the development of research applications, extraction and collection of data, and the development, management and maintenance of reliable and comprehensive data management processes and systems.

Excellent communication and interpersonal, negotiation and consultative skills and demonstrated capacity to work with sensitive issues, with meticulous attention to detail. Ability to motivate senior executives, clinicians, and managers within a large complex environment, with a proven track record in team leadership, building rapport, problem solving, change management, staff coordination and establishing trust.

For role related queries or questions contact Rebeka Freckleton on ***************@health.nsw.gov.au

The team enriching healthin millions of ways every day.