Associate Director Clinical Project Management

CTI Clinical Trial and Consulting Services; Sydney; Hybrid; AUD 180,000 - 230,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Onsite support in Sydney

Mentoring and professional development

Job summary

CTI Clinical Trial and Consulting Services in Sydney, NSW, Australia, is seeking an Associate Director of Clinical Project Management. This hybrid role oversees the end-to-end management of multiple clinical trials, ensuring alignment with ICH/GCP and regulatory standards.

You will mentor CPMs/CPCs and maintain strong sponsor relationships while guiding budgeting and timelines. The ideal candidate brings 10+ years in clinical research or project mgmt, excellent leadership, and the ability to

Qualifications

• Bachelor's degree in allied health fields with clinical trial mgmt experience preferred.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• 10+ years of clinical research or clinical project management experience.
• Ability to lead and coordinate across multiple teams and countries.

Responsibilities

• Plan, implement, and evaluate full execution of assigned clinical trials across phases.
• Oversee management of multiple trials to ensure on-time delivery and client satisfaction.
• Ensure compliance with ICH/GCP and regulatory guidelines across functions.
• Serve as senior interface with CTI and sponsor executives; manage issues and resolutions.
• Oversee study plans, timelines, budgets, and resource allocation; adapt as needed.
• Monitor project progress with PM tools; ensure timely reporting and documentation.
• Mentor CPMs and CPC staff; promote professional development.
• Review sponsor deliverables and quality of weekly/monthly reports.

Skills

Project leadership

Clinical project management

Budget management

Client relationship

ICH/GCP compliance

Cross-functional collaboration

Strategic planning

Problem solving

Education

Bachelor's degree in allied health fields (nursing, pharmacy, health science)

Tools

CTMS

Microsoft Office

Job description

Associate Director Clinical Project Management

CTI Clinical Trial and Consulting Services - Sydney NSW

Hybrid

2d ago , from CTI Clinical Trial and Consulting Services

· 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; may function as a global lead; may function in day to day operations and/or oversight of trial activities and deliverables

· 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

· Ensure that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manages the activities between all functional areas and the client

· 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; extend identified trial, staff or CTI issues to executive management as needed; actively participate in resolution activities

· Oversee preparation of all study plans and project timelines and monitor against project progress; ensure project activity compliance with Plan(s); suggest and implement alternative solutions to problems with study timelines, schedules, resources, budgets, etc. Take corrective action where necessary

· Assess resource needs with functional area managers and establish appropriate project team in conjunction with assigned CPM; monitor ongoing resource needs for project

· Ensure that appropriate project management tools are used to track and report project progress and metrics; ensure timely entry of project information by all team members throughout the life of the project

· 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; ensure that the CPMs take corrective measures where necessary to keep projects in line with budget expectations

· Ensure that the CPM assesses scope of work against client contractual agreements and assist in changes of scope orders; provide review of changes in scope notifications and work with Business Operations to ensure completion of needed contract amendments

· Synthesize and analyze new information against past experience, project information related to trial milestones in contracts and the sponsor expectations to develop strategies to facilitate effective problem solving and advancement of the project

· Keep CTI executive management and the client informed; ensure that the CPM initiates corrective action

· Conduct or attend trial team and sponsor meetings; ensure that agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions and decisions

· Review weekly and/or monthly project status reports prior to forwarding to client and assure the quality of those reports, as well as all other sponsor deliverables

· Report project progress, issues and scope of work considerations to executive management

· Provide input for new business development (NBD) proposals, assist in project budget preparation / review and represent project management services during NBD client presentations; participate in new business recruitment and marketing activities; seek NBD opportunities when appropriate and communicate these opportunities to Business Development

· Provide supervision, guidance and mentoring to CPMs while encouraging independence and refinement of the CPM’s skills; foster professional development of CPC staff

· Review and assess internal and external quality assurance reports for assigned projects and ensure corrective action as necessary by the project management team

· Provide leadership in process improvement activities and initiatives

· Provide leadership and share expertise with clinical operations staff; facilitate the development of reference and resource materials for CPMs and clinical operations; participate in staff training and development activities

What You'll Bring

• You must be fully eligible to live and work in the country you are applying from. CTI does not offer any Sponsorship
• Excellent verbal and written communication skills
• Ability to foster strong customer service and collegial relationships with clients, peers and other internal and external customers and promotes this in others; demonstrates effective interpersonal and positive leadership skills.
• Excellent organizational, record retention and time management skills
• Excellent decision-making and creative problem-solving skills
• Demonstrated critical thinking skills and ability to effectively manage shifting priorities
• Demonstrated strong knowledge and clear understanding of CTI SOPs
• Demonstrated ability to effectively manage conflict and provide leadership in the facilitating problem solving by offering solutions
• Proficient with technology and software systems
• Ability to understand, interpret, and explain complex medical details
• Ability to lead and foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals
• 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
• Demonstrated extensive knowledge of global regulatory requirements related to trial management in assigned geographical regions
• Ability to effectively manage client relations to enable achievement of their program's goals
• Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
• 10 years of clinical research experience and/or experience in clinical project management demonstrating a clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas
• Experience in management of clinical trials

Why CTI?

• Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.