Southern Star Research
Southern Star Researchis a leading Australian, privately owned, CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia and New Zealand.
Due to continued growth and a strong project pipeline, we’re looking for talented Project Managers to join our team. We’re recruiting in Sydney and Melbourne so if you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.
Reporting to the Projects Director you’ll be responsible for:
- Proactively managing all aspects of trial process including trial timelines, budgets, resources and vendor relationships;
- Acting as the central point of contact for all client trial enquiries;
- Preparing and managing project plans as well as implementing quality standards and risk mitigation strategies as required;
- Managing a cross-functional project team through all phases of the clinical trial
- Leading sponsor study start-up process, including kick off meetings, site selection as well as other various agreements and budgets;
- Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs and ICH/GCP guidelines
- Development and review of documents to ensure alignment with standard operation procedures and local regulations
- Mentor project team members when needed
To be successful in the role, we’re looking for candidates with:
- A minimum of 18 months in a project management role within CRO environment;
- A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
- Early Phase experience
- A sound knowledge and understanding of ICH-GCP;
- Exposure to a broad range of trials across multiple therapeutic areas;
- Ability to work independently
- Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).