Clinical Project Manager

Context of the Role 

The Centre for Operational and Research Excellence (CORE) is responsible for delivery and implementation of the Institute’s research strategy globally. CORE consists of four groups: Research Strategy and Services, Global Project Operations, Biostatistics / Data Science and Quality Assurance. CORE’s aim is to provide high quality expertise as well as centralised and integrated research management systems and services to ensure effective and high-quality delivery of each TGI’s research program from its design to its outputs.

The Project Operations (PO) team works closely with our Researchers to ensure studies and projects are delivered.

The Role

The Project Manager is responsible for the operational development, conduct, oversight and completion of clinical trial research projects. Excellent stakeholder management, problem solving skills, and adherence to Good Clinical Practice (GCP) principles, ethical and regulatory requirements, and applicable Standard Operating Procedures (SOPs) are essential. 

The Project Manager will join the Project Operations team and will work closely with the Innovative Clinical Trials Hub. 

The Innovative Clinical Trials Hub is a new global initiative within Project Operations, aiming to create a team of experts to support the design, delivery, and analysis of innovative clinical trials. These will include platform, adaptive trials, decentralized trials and utilize novel methods of identifying & recruiting participants, delivering trial interventions, and conducting analyses. 

Reporting Relationships

The Project Manager reports to Head of Project Operations and will oversee and direct the responsibilities of project team members. The position may also have line management responsibilities 

Duties and Key Responsibilities

• Project Delivery: Lead project team/s to deliver large and/or highly complex clinical trials with TGI and external stakeholders. This includes:
  • Establish and lead project teams, ensuring the required resources are in place including assistance with recruiting project staff
  • Ensuring team members understand and comply with TGI’s Policies and procedures, standard operating practices, ethical practice (with respect to research) and the legislative environment
  • Effective communication with stakeholders regarding operational aspects of project delivery
  • Identify key stakeholders, lead feasibility planning and site selection, manage vendor selection and contracting
  • Develop, implement and monitor project plans and budgets
  • Oversee the creation and maintenance of project-specific documents such as Protocols, Manuals of Procedures, Management Plans and participant-facing documents
  • Oversee ethics and regulatory applications, and manage site budget development and contract negotiations
  • Regularly report on project status and progress to PO Leadership Team
  • Manage and report project risks, data quality, and resolution of data queries. Ensure accurate and detailed monitoring visit reports and adherence to study protocols and regulatory requirements, including TGI SOPs and ICH-GCP.
  • Oversee site management for recruitment and data quality, and site monitoring and training
  • Manage, and support team to foster positive relationships with all key stakeholders including TGI management, TGI functional groups, committees, vendors, service providers, site staff etc.
  • Oversee and appropriately delegate all project administration e.g. study management committee meetings, project newsletters etc.
• Project Close-out: Ensure timely and successful project completion, manage data cleaning and audit processes, and communicate with statisticians and data managers. Finalize project finances and payments, oversee study closeout visits, reconcile clinical supplies, and manage the final archiving of study-related documents.
• Stakeholder Engagement: Lead or participate in discussions with stakeholders for external collaborations. Offer advice and support for projects as requested by Executive Director and/or Director Global Project Operations and/or Head of Operations
• Team Leadership and Collaboration: Manage a team of project operations staff, inspiring and guiding them in their roles. Provide project management guidance and technical expertise, and handle escalated people management issues within the team. Foster a collaborative approach across projects and the broader team.
• Pre-Project Development and Support: Support the initiation of projects including grant budgets, project proposals, leading contract negotiations in collaboration with research teams.
• Continuous Improvement and Strategic Engagement: Drive improvements in project delivery, participate in working groups, contribute to training and engage in Operations meetings. Support the implementation of PO strategic objectives and actively participate in TGI activities,
• Global Engagement: As we are a global organisation, engage with colleagues and stakeholders in other regions relative to the responsibilities of the role, accommodating global time zones where required, to ensure seamless communication and collaboration. 

As a Team Manager

The Team Manager is responsible for line management and leadership of a team of project operations staff, usually of the same role type, who work across various projects across PO. The Team Leader will:

• Onboard new team members, set and monitor goals, provide regular feedback and coach, and identify the need for and facilitate access to training.
• Contribute to capacity building within their team
• Contribute to tools and processes that build a collaborative workplace.
• Encourage and facilitate team members supporting other projects on an ad hoc basis where workload permits.
• Ensure that team members participate in and comply with their assigned training schedule 

As a Team Member:

• Participate in special projects to improve processes, tools, systems and organisation;
• Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of The Institute’s Performance Management and Development Policy;
• Demonstrate commitment to The Institute’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts. 

Work, Health and Safety

• Comply with Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at the Institute;
• Promote and contribute to a safe, secure environment for staff and visitors. 

Skills, Knowledge and Experience 

• Tertiary qualifications in a related science or healthcare discipline, with ideally at least 3 years of experience managing complex drug intervention clinical trials.
• Excellent knowledge of research and project management principles, ICH/GCP, ethical and regulatory requirements, and experience in managing NIHR budgets.
• Proven project delivery and management experience
• Excellent written and verbal communication skills and strong interpersonal skills
• Demonstrated leadership skills and the ability to guide and develop others.
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
• Strong organisational and time management skills, with the ability to understand and manage priorities
• Ability to work independently, as well as awareness of when to escalate issues
• Proficiency in Microsoft Office programs
• Ability to travel
• Flexibility to work non-standard hours of work for collaboration and contact with global teams based on requirements of the position 

About The George Institute

The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide, particularly underserved populations, by challenging the status quo and using innovative approaches to prevent and treat the world’s biggest killers: non-communicable diseases and injury.

With offices in Australia, China, India and the UK, our 700+ people support 245+ active projects and clinical trials across 50+ countries, with 400+ more staff across our social enterprises. We focus on the global health challenges that cause the greatest loss of life, the greatest impairment of life quality and the most substantial economic burden, particularly in resource-poor settings.

Together with our academic partners, UNSW Sydney in Australia, Manipal Academy of Higher Education in India and Imperial College London in the United Kingdom, we work with a global network of collaborators, undertaking clinical, population and health systems research.

What we do:

• Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery
• Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale
• Develop low-cost, innovative solutions to global unmet needs
• Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship

For more information about The George Institute, visit www.georgeinstitute.org.