Avance Clinical, a leading Australian CRO, is expanding its clinical operations and seeks experienced Clinical Project Managers and Senior Clinical Project Managers. You will drive delivery of complex trials from start-up through close-out while collaborating with biotech sponsors across Australia.

Enjoy remote work from anywhere in Australia, with flexible arrangements and a supportive leadership team in a fast-growing global CRO environment.

Avance Clinical Pty is seeking an experienced Study Start-Up (SSU) Specialist I based in Australia, with remote work option within Australia. You will drive site activation, budgets, regulatory submissions, and ethics committee interactions, reporting to the Project Manager and liaising with sponsors.

Ideal candidates have CRO/Pharma SSU experience, ICH-GCP knowledge, and strong communication skills. Travel to sites may be required; supportive team culture is emphasized.

Avance Clinical Pty is seeking a Project Manager/Senior Project Manager for their clinical trials team based in Melbourne, Australia. The successful candidate will manage clinical projects from start to finish, ensuring they are delivered on time and within budget. With a background in health or life sciences and 5 to 10 years of CRO/Pharma experience, you'll thrive in a fast-paced environment. The position allows for flexible working options and offers a competitive salary along with additional benefits.

Project Manager / Senior Project Manager (Clinical Trials)

Join our amazing Australian based Project Delivery team! Great culture with long term career options & remote working from anywhere in Australia.

Project Manager / Senior Project Manager / Australia

If you've had full accountability for managing Clinical Trial projects, then we'd love to hear from you. We're Australia's fastest growing CRO and a multi award winning business! Our service offering is quality based which is directly reflected in the people that join us. Due to continued business wins we're looking for a number of suitably qualified and experienced Project Managers / Senior Project Managers.

We're Avance Clinical, a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry, you'll know that we are experts in our field and have an unrivalled reputation for providing high quality service.

Responsibilities

Managing clinical projects from commencement to completion, you will be the interface between our clients and sites, managing multiple trials across many therapeutic areas at any one time ensuring the studies are delivered on time and within budget. This role is perfect for someone who is driven and likes working in a fast paced CRO.

What we offer

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are working together on a common goal
• Flexible work options
• Great tools / tech to do your job
• A competitive salary & an extra days holiday for your birthday!

What you'll need to succeed

• Tertiary qualifications in health / life sciences.
• 5 to 10 years experience in a CRO / Pharma environment having worked on fast paced early phase clinical trials for at least 5 years.
• You will need to have excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate several tasks simultaneously.
• You must have a self starter attitude, be flexible and be adaptable to the ever changing environment of working for a fast paced CRO.

Short term contract (6 Months), office-based positions at our office in Sydney/Adelaide/Melbourne

Who are we?

We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field.

Why should you join Avance Clinical?

At Avance we know our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We're seeking people that thrive in a positive environment, who are inquisitive and keen to have a genuine opportunity to learn and grow in a business that is expanding.

The role

The Clinical Trial Associate is responsible for supporting the Clinical Operations Team in an administrative capacity ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Please note - this role is office based 5 days per week.

Core Responsibilities

• Support all aspects of clinical operations from study inception to completion, including:
  • Organise, facilitate and take minutes for project/study team and functional group meetings.
  • Establish, maintain and track completeness of Trial Master Files.
  • Prepare Investigator Site Files and establish study documentation for assigned studies as required. o Liaise with study team members to ensure good communication across each study.
  • Prepare and collect site documentation in conjunction with Project Manager and Clinical Research Associate, from study start up through to end of study.
  • Manage receipt and shipping of study documentation to Investigator sites, maintain internal trackers.
  • Maintain internal databases and assist the Clinical Operations team in ad hoc duties.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.

Qualifications, Skills and Experience

• Bachelor's level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.
• Previous exposure to a Clinical Trials environment (desirable).
• Awareness of ICH GCP Guidelines and other applicable regulatory requirements (desirable).
• Clear understanding of the requirement to adhere strictly to client confidentiality.
• Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
• Demonstrated ability to take initiative in problem solving and in exercising good judgment.
• An understanding of Privacy Legislation as it applies to the Clinical Trial Environment (desirable).

What next?

As a growing business we're looking for likeminded people to join us - we hope that's you.

At Avance difference is encouraged, its celebrated and it's something we strive for. We empowercultural, disability, LGBTI+, and gender equality.

Avance Clinical is seeking a Clinical Trial Associate to support the Clinical Operations team in an administrative capacity. The role is office-based, five days per week, across Sydney, Adelaide or Melbourne.

You'll help manage Trial Master Files, site documentation and study communication, ensuring compliance with SOPs and ICH-GCP guidelines. The successful candidate will have a life sciences degree and prior exposure to clinical trials, with strong written and verbal communication skills and