Southern Star Researchis a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.Due to continued growth and a strong project pipeline, we're looking for a talented, full-time Head of Projects to join our team in Sydney, Australia. The successful candidate will embody the ethical tone of Southern Star Research, including directly overseeing the administration and implementation of Southern Star Research's 'Code of Business Conduct and Ethics'.If you're interested in joining an innovative, exciting, Australian owned CRO, we'd love to talk to you.About the roleReporting to the Chief Executive Officer you will be responsible for:Recruitment, retention and management of a team of Project Managers and the Associate Head of Project Operations (AHPO) accomplished in clinical trial service delivery and the ongoing management of resource levels to ensure high quality project delivery.Identifying individual and departmental training needs and implementing suitable formats to increase competency.In collaboration with the AHPO assume responsibility for high quality service delivery across the Project Management team, ensuring project execution and revenue recognition in accordance with contracted scopes of work.Provide regular reports of Project activity, financial status and forecasting to Senior Management and the Board of Directors.Assume overall responsibility for the department budget working within agreed boundaries and with focus on achieving financial targets and implementing department initiatives to meet overall business needs and objectives.Work with the CEO to grow and evolve the Project Operations Department for efficient contracted service delivery and continuously meets the overall business needs and allows nimble resourcing solutionsOversee the development and maintenance of Project Operational QMS documentation to ensure consistent, high-quality services delivery in compliance with GCP, ISO and all applicable regulatory standards. Southern Star Research has ISO9001 certification.Attend, support and contribute to Business Development activities and other client interfaces.Liaise with clients on project related matters regularly and as part of structured escalation and governance pathways.Lead and develop pre-emptive strategies to manage the impact of key industry issues that can impact either directly or indirectly on the business.Perform any additional duties of the role as assigned.To be successful in the role, we are looking for candidates with:Bachelor's degree required; Medical/Science background is preferred. MSc/PhD desirable.Minimum 15 years Clinical Research experience in complex, matrix organisations with a minimum of 3 years line management experience and 2 years in departmental management.Extensive experience in Project Operations with a proven track record in Project Management and a full understanding of the clinical trial process leading cross functional teams. Early phase clinical trial experience is preferred.Previous CRO experience at a senior level is essential.Comprehensive working knowledge of ICH-GCP, ISO 14155, and all applicable local regulations is essential. Knowledge of Codes of Federal Regulations and experience of Project Operations in other jurisdictions (US/Europe/APAC) preferred.Willingness to travel interstate and occasional O/S travel possible.Why Southern Star Research?Southern Star Research is a growing business, and this is an ideal opportunity for someone who is looking to lead the Project Operations Department and contribute towards our expansion into the APAC region. Southern Star Research are also proud to be certified as a Great Place To Work!We offer:An attractive remuneration and benefits package;Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;Career stability and security;Office located in Gordon – under cover parking provided and close to public transport;STAR day – one extra day off per year for you to recharge and more!Inclusivity, Diversity and EqualityOur commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.Please note that only successful candidates will be contacted.Keep up to date with the latest news, updates and promotionsCopyright 2024 Southern Star Research Pty Ltd#J-18808-Ljbffr