Clinical Project Assistant

1 month ago

Melbourne, Australia Gilead Sciences Full time

For Current Gilead Employees and Contractors:
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

**Job Description**:
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

You will support other Clinical Operations team members in the start-up, maintenance and close-out of clinical studies. You will track and prepare study-specific information, review and participate in the quality assurance of data and/or documents, arrange and assist with meetings and meeting logistics, and assist with development of documents and standard forms.

EXAMPLE RESPONSIBILITIES:
- Tracks and prepares study-specific information using databases, spreadsheets, and other tools.- Reviews and participates in the quality assurance of data or documents.- Arranges meeting logistics, agendas, and assists with minutes.- Interacts with other departments, as needed, to complete assigned tasks.- Assists with development of documents and standard forms.- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements

**REQUIREMENTS**:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience:
- MA /MS /PharmD /PhD with some relevant clinical or related experience in life sciences.- BA / BS / RN with 1 or more years’ relevant work experience.- Some general clinical or business knowledge and experience is preferred.

Knowledge & Other Requirements:
- Demonstrated ability to be a fast learner.- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.- Aptitude to learn Gilead’s business and the biopharma industry.- Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) is preferred.- Understands how to use basic office programs / tools.- Ability to communicate in a clear and concise manner.- Ability to support a team-oriented, highly-matrixed environment.- Ability to execute multiple tasks as assigned.- When needed, ability to travel.

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