Associate Director Clinical Operations

3 weeks ago

Sydney Central Business District, Australia HAYS Full time

Great opportunity for an entrepreneurial Associate Director Clinical Operations to join a growing organization

**Your new company**

Innovative global pharmaceutical service provider looking to expand their footprint in Australia is looking for an experienced Associate Director of Clinical Trials Operations in Sydney or Melbourne to join their global team. This is a company growing at rapid pace where someone with entrepreneurial spirit and hands-on attitude would thrive.

**Your new role**

You will be a critical member of a highly innovative and entrepreneurial team driving technological solutions to clinical trial inefficiencies, rising costs of drug development, lack of utility of technological advances in healthcare/pharma tech, and fragmented data silos, to ultimately increase patient access to clinical trials and novel therapeutics.

The Associate Clinical Research Lead will be expected to lead Clinical Trial Operations in regional and local level. You will be working closely with site staff helping them to set up clinical research infrastructure at the sites that will run clinical trials. You will be responsible for providing expertise on development and implementation of FICS at Clinical Trial Sites.

You will work closely with other members of the global team in creating policies, procedures, and novel technology infrastructure, as well as designing methods for delivery of novel technology at clinical sites.

Key responsibilities:

- Provide operational expertise on Sponsor and Site interface of FICS
- Provision of expert knowledge on clinical trial compliance with local and global regulations
- Support vendors with implementation of novel technology
- Participate in problem-solving discussions with internal and external stakeholders
- Work closely with Clinical Transformation Lead to develop training program and tools
- Identify pain points in major workflows by contributing to development of wireframes/templates and tools to address these challenges
- Surface suggestions on improvements in software and processes
- Assist with development of novel technology (FICS), data capture forms and instructions
- Expert with clinical operations systems such as EDC, RTSM, CTMS, and eTMF
- Contribute your professional understanding of different core functions within the Clinical Trial ecosystem ie. Clinical Operations, Clinical Development, Data Management, and Biostats
- Develop, create, and track SOPs, Policies, and Procedures

**What you'll need to succeed**
- Strong experience running Clinical Operations autonomously, with a diverse background working with Sponsors, CROs, and Clinical sites
- Hands-on experience of managing project and study budgets
- Previous experience working in a Clinical Research Associate role
- Strong experience working in Oncology Clinical Trials
- Highly motivated, hands-on attitude, with strong negotiation and interpersonal skills
- Ability to influence strategically across all levels of the organization, with demonstrated ability to shape and deliver business cases
- Willingness to travel both domestically and internationally
- Location: Based either in Sydney or Melbourne

**What you'll get in return**
- This is an exciting time to join the company as they expand their presence in Australia.
- You will be working in a fast-paced environment with a strong focus on optimizing current practices in Clinical Research.
- Full-time working from home (with option to work from the Sydney office).
- Excellent remuneration packages and other benefits on offer.

**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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