Clinical Project Manager

Context of the Role  

The Project Operations (PO) team works closely with our research teams, external partners and collaborators to ensure project aims are achieved. The team is primarily responsible for the setup, conduct and overall delivery of clinical trial projects across all research programs in the Institute according to best practice guidelines and research budgets.

The Project Manager will join the global 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.

The Role

The Project Manager is a global role based in the TGI UK office within the Centre for Operational Research Excellence (CORE).  

The Project Manager will undertake the management of one or more projects delivered alongside the Innovative Clinical Trials Hub. These projects may involve utilizing routinely collected data, decentralized trial elements or pragmatic/efficient trial designs.  The Project Manager will take responsibility for the global central coordination of projects sponsored by TGI., working closely with project teams based in Regional Coordinating Centers across the world, ensuring each project is delivered according to regional regulations and guidelines.

The Project Manager may also work with the Innovative Clinical Trials Hub team on the development, design and implementation of processes, procedures and projects to support the delivery of the Hub.

Reporting Relationships

The Project Manager reports to the Operations Manager, Clinical Trials and will work with the Chief Investigator to oversee and direct project activities across multiple Regional Coordinating Centres.

Duties and Key Responsibilities

The Project Manager will maintain effective professional relationships with the internal project team, regional investigators, internal and external stakeholders, and vendors. The Project Manager will provide clear guidance to the wider project teams on project specific deliverables.

All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP (if applicable) and applicable regulatory requirements.

Project Kick-off

• Lead relevant project specific meetings including formal kick-off meetings.
• Develop project plan and other internal project management documents.
• Lead development of project specific documents such as protocol and participant information forms as requested.
• Coordinate the feasibility planning and selection process of regional coordinating centers and project sites.
• Identify project specific activities that need to be in sourced, outsourced and be involved in the selection of suitable vendor/s.

Project Implementation and Closure

Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including the following:

• Develop and manage the project budget.
• Manage project scope.
• Monitor project against timelines.
• Oversee development of project documentation e.g. site manuals, operating procedures etc.
• Compliance with ICH GCP and all other applicable global ethical and regulatory requirements.
• Manage trial committees e.g. Steering, Data Safety Monitoring Board.
• Identification of potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable.
• May undertake HRA, ethics and regulatory submissions if not delegated.
• Oversight of project and site contracts negotiation and development.
• Oversee the set-up of sites in accordance with SOPs, protocol, and all applicable regulatory guidelines.
• Manage project resourcing requirements.
• Manage project supplies/materials required.
• Manage site monitoring and training requirements.
• Review and sign off monitoring visit reports.
• Manage project administration e.g. study management committee meetings, project newsletters etc.
• Coordinate and drive internal project team to meet project specific deadlines.
• Drive project team to deliver clean, accurate and verifiable data for interim and final analyses.
• Ensure patient safety and adverse/serious adverse events are reported according to ethics committee and regulatory requirements.
• Initiate filing conventions for the project and ensure the team is trained on requirements.
• File and archive clinical project data at end of project.
• Provide or contribute to progress reports for project originator and other stakeholders.
• Maintain regular contact with project team.
• Where applicable, consult with Data Management and Statistics Divisions on project specific deliverables.

Compliance and Training

• Mandatory attendance at core department and project specific training.
• Attend and actively participate in project management and organisational meetings and workshops.
• Comply with all required project specific and George Institute specific systems. 
• Comply with all applicable regulations, guidelines, SOPs and project specific requirements.  Complete and document all necessary training in the allocated system/form. 
• Ensure project team members have access to necessary project specific training.
• Contribute ideas and experiences to improve processes, tools, systems and organisation.

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.

As a Team Manager:

• Ensure direct reports understand and comply with TGI’s Policies and procedures, standard operating practices, ethical practice (with respect to research) and the legislative environment.
• Be responsible for managing performance of direct reports, including the completion of plans and agreeing on work and personal objectives and reviewing such plans and objectives, in accordance with TGI’s Performance Management and Development Policy.
• Act as a role model and ensure the team’s commitment to TGI’s values, ensuring direct reports perform to a 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

 Essential

• Degree or equivalent experience in a related science or health care discipline.
• Relevant experience in clinical trial project management working within an NHS, academic, CRO or pharmaceutical environment.
• Experience of protocol development and submissions to ethical and regulatory authorities.
• Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders.
• Experience in managing project budgets (both commercial and non-commercial) and reporting requirements.
• Proficient in use of the Microsoft office suite of products including Word, Excel, PowerPoint and Outlook.
• Strong problem solving, analytical skills, and strategic thinking.
• Strong leadership and mentoring skills.
• Ability to see the big picture, yet still focus on detail.
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
• Strong focus on quality of work.
• Ability to travel.

 Desirable

• Experience with routine data collection and data linkage.
• Experience with registry studies.
• Experience and interest in innovative, novel or decentralized clinical trials.

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.