Associate Director Clinical Project Management

CTI Clinical Trial and Consulting Services; Sydney; Hybrid; AUD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Award-winning culture

Job summary

CTI Clinical Trial and Consulting Services seeks a senior clinical project leader to drive global trials from planning to analysis. You will ensure compliance with ICH/GCP and regulatory guidelines while coordinating CPMs and CPCs across functions and with sponsors.

The role requires a Bachelor’s in allied health, plus about 10 years in clinical research or clinical project management, with demonstrated leadership and budget stewardship.

Qualifications

• 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

Responsibilities

• Plan, oversee and deliver multiple clinical trials from planning through analysis; may function as global lead
• Ensure adherence to ICH/GCP guidelines, regulatory requirements and trial procedures
• Coordinate CPMs/CPCs to align activities across functional areas and with the sponsor
• Engage executive management and clients to resolve issues and communicate progress
• Develop study plans and timelines; monitor progress and adjust resources and budgets as needed
• Assess resource needs with area managers and form project teams accordingly
• Utilize project management tools to track progress and ensure timely reporting
• Train project teams and oversee staff development
• Manage budgets and ensure alignment with milestones; implement corrective actions when necessary
• Review scope of work against contracts and assist in contract amendments
• Synthesize new information to drive problem solving and project advancement
• Keep CTI and clients informed and escalate issues when needed
• Lead trial team and sponsor meetings; prepare agendas and minutes
• Review status reports for quality before client submission
• Contribute to new business development proposals and client presentations
• Provide supervision and mentorship to CPMs and CPCs
• Assess QA reports and drive corrective actions; lead process improvements
• Share expertise with clinical operations and develop reference materials

Skills

Excellent communication

Client management

Leadership

ICH/GCP knowledge

Global trial management

Healthcare background

Education

Bachelor’s degree in allied health fields such as nursing, pharmacy or health science

Job description

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. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

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; 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; elevate 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.

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 a @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process