Clinical Trial Site Engagement Lead

2 weeks ago

Sydney, Australia Amgen Full time

Career Category

Clinical

**Job Description**:
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

LIVE - What you will do

Let’s do this. Let’s change the world. In this new and vital role, you will develop, implement and maintain coordinated site engagement and operations at key/targeted sites, support global study strategy plan to accelerate development of marketed and early pipeline products. You’ll also maintain an effective collaborative partnership with all stakeholders, ensuring aligned and synergistic approach to sites’ Amgen experience. For this role you can be based in any Australian capital city. Some travel required to sites, congresses and meetings.

Key Responsibilities include:
Leadership of Operational Site Engagement
- Drive expansion of strategic relationships and meet clinical operational needs across all therapeutic areas and studies
- Assimilate and report external feedback to evaluate and propose process efficiencies, focus and direction

Locally accountable for key, targeted sites execution of clinical studies- Build and develop strong relationships with key sites to engage with Amgen as choice for clinical trial participation- Regular communication with key sites to connect on all trials/all stages to determine trends and opportunities and enhance sites’ Amgen experience

Global Site Operations Quality Management- Actively participate in role forums including local/global functional and cross functional initiatives- Participate in Functional Management Team Meetings and country-level project review meetings as required

WIN - What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a hardworking team player with these qualifications and experience:
- Relevant tertiary qualifications- Experience in a similar role in life sciences or medically related field, including biopharmaceutical clinical research experience (obtained working on clinical trials in a biotech, pharmaceutical or CRO company)- Expertise and in-depth understanding of site engagement with clinical trials- In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines- Project and Program management including oversight of quality, study deliverables, budgets and timelines- Clinical trial management systems and reporting tools and utilization of Key Performance Indicators (KPIs)- Fluency in English, both oral and written communication- Residency and permission to work in Australia essential

THRIVE - What you can expect from us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional, personal growth and well-being.- Vast opportunities to learn and move up and across our global organisation- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act- Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

At Amgen we are committed to doing everything we can to deliver for patients, to keep our staff and their families safe, and to help the communities where we live and work reduce the number of people exposed to COVID-19. As a science-based company, we strongly believe that it is our role to lead the way and therefore it is a requirement that all Amgen Australia employees must be fully vaccinated (certain exemptions will be considered on a case-by-case basis).

.

  • Clinical Trial Manager

    4 weeks ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Overview** - Successfully manage and oversee clinical trials - Work directly for a Sponsor - Flexible work from home arrangements - Sydney based role **Benefits**: - Work directly for a top tier pharmaceutical company - Close knit team with lots of developmental and training opportunities - Attractive salary package - Exposure to an exciting pipeline of...

  • Clinical Trial Assistant

    4 weeks ago

    Sydney, Australia IQVIA Full time

    Are you a** Clinical Trials Assistant (CTA)** looking for a new and exciting challenge with opportunity for ongoing support and growth? Are you looking for a career and not just a job? Then we have the role for you! **Job Overview**: - Assisting preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. -...

  • Clinical Trials Assistant

    1 week ago

    North Sydney Council, Australia IQVIA Full time

    Job Overview:We are currently seeking Clinical Trials Assistants ( CTA) to join our Functional Service Partnerships team in a client facing role. This role does require onsite with our client 2 days a week in North Ryde. As a vital part of our team, our Clinical Trials Assistants( CTA) perform daily administrative tasks to support to clinical projects and...

  • Regulatory & Site Activation Specialist - Australia

    4 weeks ago

    Sydney, Australia Worldwide Clinical Trials Full time

    **Requisition Number** **6513** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Trial Assistant

    4 weeks ago

    Sydney, Australia IQVIA Full time

    **Job Overview**: - Assisting preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. - Assist with accurately updating and maintaining clinical documents and systems (e.g., eTMF and CTMS) that track site compliance and performance within project timelines. - Act as a central contact for the clinical team...

  • Medical Oncology Fellow

    4 weeks ago

    Sydney, Australia Macquarie University Hospital Full time

    PRIMARY DETAIL THE ROLE- Work with a state of the art clinical trials oncology team on the Macquarie University campus- Play a key role in the development of new medicines in oncology- Competitive base salary- Be part of a university owned, innovative academically integrated healthcare organisation where professional development, ongoing education and...

  • Clinical Trial Research Monitor

    4 weeks ago

    Sydney, Australia University of New South Wales Full time

    **Job no**: 523008 **Work type**: full time **Location**: Sydney, NSW **Categories**: Clinical/Medical Research **Clinical Trial Research Monitor - National Drug and Alcohol Research Centre (NDARC) - Sydney based** - **Employment Type**:Full - time (35 hours a week) - **Duration**:1 Year Fixed Term contract (with possible extension) -...

  • Clinical Medical Manager

    4 weeks ago

    Sydney, Australia Novo Nordisk Pharmaceuticals Full time

    Are you passionate about building relationships with Key Opinion Leaders (KOLs) and driving local strategy with insights from leading therapy area experts? We are seeking an experienced and detail-oriented Clinical Medical Manager (CMM) to join our Novo Nordisk team in Australia as we have multiple roles and are open to people located in Sydney, Melbourne or...

  • Cra Ii

    4 weeks ago

    Sydney, Australia Syneos Health Clinical Full time

    **Description** **Clinical Research Associate II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...

  • Trial Coordinator

    3 weeks ago

    Sydney, Australia UNSW Australia Full time

    Trial Coordinator - Psychology Job no: 524338 Work type: part time Location: Sydney, NSW Categories: Research Administration support One of Australia’s leading research & teaching universities Vibrant campus life with a strong sense of community & inclusion Enjoy a career that makes a difference by collaborating & learning from...

  • Trial Coordinator

    3 weeks ago

    Sydney, Australia University of New South Wales Full time

    One of Australia’s leading research & teaching universities Vibrant campus life with a strong sense of community & inclusion Enjoy a career that makes a difference by collaborating & learning from the best At UNSW, we pride ourselves on being a workplace where the best people come to do their best work. The School of Psychology at UNSW is the leading...

  • Clinician/Rater - Psychiatry (Depression) - Contractor- Australia - Home-based

    1 week ago

    Sydney, Australia Worldwide Clinical Trials Full time

    Requisition Number7837Employment Type:Contractor – Not pushed to Sage Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our...

  • Study Start Up Specialist

    3 weeks ago

    Sydney, Australia Novo Nordisk AS Full time

    Are you seeking a contract role in Study Start-Up? Would you like to be involved in planning and executing the Study Start-Up activities in the allocated clinical trials? Do you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? If so, keep reading – we may have just the right job for you!...

  • Clinical Quality and Training Manager

    5 days ago

    Sydney, Australia Novo Nordisk Full time

    **About the department** Novo Nordisk is a leading global healthcare company with nearly 100 years of innovation and supervision in diabetes care. The Novo Nordisk Oceania affiliate is a high performing and growing organisation operating within a dynamic healthcare environment across Australia and New Zealand. Our primary therapy areas are diabetes and...

  • Clinical Research Associate Ii

    4 weeks ago

    Sydney, Australia NES FIRCROFT Full time

    BH-245772 Posted: 31/10/2023 - Competitive base, allowances & career progression- Australia New South Wales Sydney- Permanent- Life Sciences**Clinical Research Associate II (CRA 2)** - ** Opportunity to work with a global CRO, growing in the ANZ market**: - ** Excellent work benefits & generous salary packages on offer**: - ** Remote working opportunity...

  • Quality Assurance Manager

    4 weeks ago

    Sydney, Australia University of New South Wales Full time

    **Job no**: 515350 **Work type**: full time, part time **Location**: Sydney, NSW **Categories**: Risk & Safety, Clinical/Medical Research **Quality Assurance Manager - Clinical Research Unit** - Employment Type: 0.8 FTE - Full time (28 - 35 hours/week) - Duration: 2 year fixed term contract - Remuneration: $112,154 to $126,366 (plus 17% super & leave...

  • Real World Evidence Lead

    1 month ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits** Opportunity to make a real impact on patient care through innovative use of real-world evidence. Engage in varied and challenging projects that drive meaningful insights and improvements in healthcare. Competitive salary and ability to work from home part of the week. **About the Company** Our client is a pioneering company dedicated to...

  • Site Activation Specialist

    4 weeks ago

    Sydney, Australia Novasyte Full time

    We are currently looking for a Site Activation Specialist on a full time 12 month fixed term Paternity Leave role. In this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the main liaison between investigative sites, Site Activation Manager (SAM), Project Management team, managing and executing start up and site...

  • Client Operational Strategy Manager

    4 weeks ago

    Sydney, Australia Novotech Asia Full time

    **Client Operational Strategy Manager** Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives. Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and...

  • Adult Clinical Lead, Inpatient

    1 month ago

    Sydney Western Suburbs, Australia Wavelength International Full time

    **The Position**: As the Adult Clinical Lead, Inpatient & Community you will be responsible for delivering timely expert mental health assessments and care in various settings, including mental health inpatient and community, as well as general hospital and clinical settings. This position emphasises adult mental health care and involves collaboration with...