Project Associate II

Project Associate II / Senior Project Associate (Clinical Trials) Office based opportunity to join our project delivery team. Great long term career options. Project Associate II / Senior Project Associate | Office based (Sydney, Melbourne or Adelaide). Great opportunity to join our high performing project delivery team and have a pathway to become a Project Manager. 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 and have an exceptional reputation for supporting our people. Why should you join Avance Clinical? We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team & support. We’ve doubled in size in the last 3 years and have promoted over 23% of our people in the last 12 months. Broad Purpose The Senior Project Associate (Snr PA) works alongside the Project Manager (PM) to plan and execute projects, 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 Snr PA may also act as the Project Lead on less complex projects. Core Responsibilities include With minimal oversight by the respective PM, supports all aspects of project delivery from study commencement to completion, including: Establish and configure project management systems, processes and trackers during the initiation phase of a study. Draft Kick-Off Meeting materials and liaise with all stakeholders to facilitate the meeting. Draft project plans for review by the Project Manager. Maintain project information in the Clinical Trial Management System (CTMS), including project milestone tracking. Accurately track project action items, risks, and issues. Organise, facilitate, create agendas and take minutes for project/study team meetings. Lead internal and external project/study team meetings. Liaise with cross-functional team members to ensure good communication across each study. Trial Master File (TMF) document review, metadata update and management. Facilitate quarterly reviews of the TMF with the PM. Track vendor invoices, site invoices, and investigator grants payments on assigned projects. Assists the PM with monthly revenue recognition and forecasting, and reviews customer invoices for project labour and expenses. Key Performance Indicator (KPI) tracking and reporting to Sponsor. Source, supply (shipping and tracking), and maintain drug/study supplies. In-house contact for administrative protocol queries, and study related questions. 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. Qualifications, Skills, and Experience Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience. Previous experience as a PA (or equivalent) in a CRO or Pharma company for at least 2 years. Previous experience as a Clinical Trial Assistant (or equivalent) is highly regarded. Working knowledge of ICH GCP Guidelines 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 (desirable). Very minimal level of travel may be required (up to 10%). 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 next? 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. At Avance difference is encouraged, its celebrated and it's something we strive for. We empowercultural, disability, LGBTI+, and gender equality. Project Associate / CTA / CRC / CRO / Life Science / Adelaide / Sydney / Brisbane / Melbourne Apply For Job #J-18808-Ljbffr