AddressWho 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. We’re the fastest growing CRO in Australia.
Broad Purpose
The Project Director II (PD II) is responsible for planning and executing or overseeing projects by coordinating staff and processes to deliver projects on time, within budget and with the desired outcomes while ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. The PD II may also line manage a team of Project Managers (PMs) and Project Associates (PAs).
Core Responsibilities
- Provide guidance and support to Project Managers (PM) to ensure high quality project delivery across the following areas:
- Effective Sponsor communication to proactively manage project timelines, expectations, risks, and issues.
- Communication with internal cross-functional teams and external stakeholders (including third party vendors and site staff) to execute projects within agreed timelines.
- Development of appropriate study plans and documents to support the effective execution of all Project Management activities.
- Consistent and accurate identification, management and reporting of study-specific risks.
- Project financial management including revenue recognition, accurate forecasting and contract management, sponsor invoicing, and vendor payment management.
- Develop effective relationships for assigned Sponsors to successfully manage sponsor grievances and drive strategic partnerships.
- Manage PM/PA resource assignments across the department in conjunction with the PD team, proactively projecting PM/PA resource need.
- Monitor line reports’ compliance with use of expected company systems and processes; training completion and timecard entry, leave entitlement administration; and expense processing.
- Actively manage the performance of line reports and individual career development strategies.
- Implement and support staff retention initiatives, drive staff recruitment (including interviews and probation period management) and manage staff severance.
- Autonomously manage all contracted services and vendors for clinical projects to ensure that projects are commenced and completed within defined scope, timelines, and budget.
- 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.
- Provide guidance and mentoring to less experienced project management staff members and participate in training initiatives.
Qualifications, Skills and Experience
- Bachelor’s level degree in life sciences, pharmacy or nursing.
- Previous experience as a Project Director in a Contract Research Organisation for at least 2 years, with a minimum of 2 years’ experience line managing staff in a CRO or Pharma company.
- Previous training and a working knowledge of ICH GCP and applicable regulatory requirements.
- 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.
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to work in, and be supportive of, a positive and dynamic team culture.
- Ability to travel. Minimal level of travel may be required (up to 20%).
- Can build and maintain positive relationships with management, peers, and subordinates.
- Ability to work independently or in a team environment as needed.
- Display strong analytical and problem-solving skills.
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 – you can work from home
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday!
What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered
Alternatively, you could pick up the phone and call our Senior Talent Acquisition Specialist Adrian Bedford 0406 574*** / **************@avancecro.com
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
Project Director / PD / Senior Project Manager / Clinical Project Management / CRO / Biotech / Clinical Trials / Pharma / Adelaide / Brisbane / Melbourne / Sydney / Australia
