Global Cta

3 weeks ago

Sydney Central Business District, Australia HAYS Full time

Global Clinical Trials Associate

**Your new company**

Hays are working with a biotechnology sponsor that are continuing to expand their APAC presence. With a talented Clinical Research team now present in Australia and New Zealand running local and global cutting-edge trials, the Global CTA will ensure trials are run in accordance with ICH-GCP, regulatory and quality requirements. You will be supporting Clinical Research professionals locally and globally that form a broad international team. This role has very flexible working arrangements, with the expectation of the Global CTA to work from home/remote, anywhere in Australia or can use the Sydney based office if that is local to you.

**Your new role**
- Support the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.
- Support the Study Manager in global study delivery and ensure that your components of clinical studies are executed to expected and specified quality standards, within timelines and budget.
- Support the alignment of study goals with clinical operations goals and objectives under direction of the Study Manager.
- Support study vendor management in addition to other study management activities assigned.
- Create and maintain study level SharePoint and CST distribution lists, and set up the study in the appropriate systems e.g eTMF, CTMS.
- Ensure system access is granted and managed appropriately across the study life cycle, support user account management for systems used in study.
- Support and assist in the set-up of the study in relevant trial registries.
- May assist in the review of study-related documents as delegated by the Manager (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).

**What you'll need to succeed**
- You must be an Australian Citizen or permanent resident and be based in Australia.
- You will have a strong background as a CTA, with 2 years industry experience and hold a degree in the life sciences.
- You will enjoy working with sites to manage clinical trials with a high degree of quality, attention to detail and passion.
- Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
- Experience in early phase Oncology trials will be highly regarded.
- You will be an autonomous CTA, independent and confident in meeting the expectations of a remote workforce.

**What you'll get in return**
- You will be joining a fantastic company that are at an exciting stage of growth, with an extensive study pipeline, plans for further growth in the APAC region and dedicated learning and development investment.
- You'll be working alongside the regional teams in a global capacity, stretching your networks overseas.
- This is a home-based role, anywhere in Australia. If you are based in Sydney and would like to attend the office, you can do so.
- You will benefit from a favourable work-life balance as well as learning, development and future progression opportunities.
- The company offers excellent remuneration and bonus packages, and you will join a rewarding, high performing work culture.

**What you need to do 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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