Associate Director Clinical Project Management in Sydney

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.

What You'll Do:

• Plan, implement, facilitate and evaluate the full execution of assigned clinical trials; oversee management of multiple clinical trials from the planning phase to the analysis phase for delivery to client.
• Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures.
• Serve as primary senior interface on the project with executive management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues.
• Oversee preparation of all study plans and project timelines and monitor against project progress; ensure project activity compliance with Plan(s).
• Assess resource needs with functional area managers and establish appropriate project team in conjunction with assigned CPM.
• Ensure that appropriate project management tools are used to track and report project progress and metrics.
• Ensure training of assigned project teams; participate in staff training for projects, dependent upon expertise.
• Oversee the management of budgeted hours by the CPMs, who evaluates and manages regional project budget against project milestones.
• Synthesize and analyze new information against past experience, project information related to trial milestones in contracts and the sponsor expectations.
• Conduct or attend trial team and sponsor meetings; ensure that agendas and minutes are effectively prepared.
• Provide input for new business development (NBD) proposals, assist in project budget preparation / review.
• Provide supervision, guidance and mentoring to CPMs while encouraging independence and refinement of the CPM’s skills.
• Review and assess internal and external quality assurance reports for assigned projects.
• Provide leadership in process improvement activities and initiatives.

What You'll Bring:

• Excellent verbal and written communication skills.
• Ability to foster strong customer service and collegial relationships with clients, peers and other internal and external customers.
• Excellent organizational, record retention and time management skills.
• Demonstrated critical thinking skills and ability to effectively manage shifting priorities.
• Demonstrated strong knowledge and clear understanding of CTI SOPs.
• Proficient with technology and software systems.
• Ability to lead and foster collaboration and coordination amongst a diverse group.
• Demonstrated extensive knowledge and clear understanding of overall drug development process and medical/pharmaceutical terminology.
• Demonstrated expertise in ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
• Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience.
• 10 years of clinical research experience and/or experience in clinical project management.

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients.

Important Note: In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address.