Operations Manager, Clinical Trials

Position Description 

REPORTING RELATIONSHIP: Director Global Project Operations

CAREER STEP: Specialist (Projects)

EMPLOYMENT DURATION: Per contract (2-3 years)

START DATE: ASAP 

About The George Institute for Global Health

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.

Our experts are among the most cited globally, bestowed accolades for excellence and innovation, and regularly participate in policy fora. Our research is published in leading academic journals, referenced in policy documents, and recognised for its excellence, innovation and impact. We are designated a WHO Collaborating Centre (WHO CC) for Injury Prevention & Trauma Care, and a WHO CC for Population Salt Reduction. Since 1999, we have raised more than $1 billion for research and produced over 10,000 peer-reviewed publications and other academic outputs.

The Global Women’s Health Program was established in 2018. With staff and projects across all TGI offices, the program is led by Professor Hirst in the UK office. The program conducts research and policy work looking at sex and gender differences in health outcomes, non-communicable diseases in pregnancy and women, women specific conditions such as endometriosis and cervical cancer, and women’s health and environmental change. 

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.uk  

Context of the Role  

The Project Operations group primarily leads on the design, conduct and analysis of national and international multi-centre trials and staff, with specialist disease and methodological knowledge, and has input at all stages of the trial lifecycle; thus ensuring all activities are conducted according to the principles of ICH GCP and in compliance with the appropriate regulatory and ethical requirements.

The group comprises of multiple project teams globally, some overlapping. The project teams work closely with Research teams on specific projects, which form part of specific research programs. 

The Role

The Operations Manager is a leadership role within Project Operations and is responsible for establishing the Centre for Operations and Research Excellence (CORE)  in the UK and coordinating the day-to-day PO activities between TGI and Imperial College Trial Unit (ICTU).  

Working closely with the Director, Global Project Operations and other multi-professional groups, this role requires a thorough understanding of, and expertise in, the conduct of clinical trials, research management and governance. The Operations Manager will undertake a wide range of trial activities from development of initial concept and accurate costing for grants through senior oversight of the conduct of studies to successful delivery to time and within budget. This will require strong and effective working relationships to be established and maintained between other members of the CORE team, academic and professional colleagues, globally.  

The Operations Manager will ensure projects are resourced effectively, managed efficiently, achieve project objectives and are conducted within allocated budgets and agreed timelines in accordance with Good Clinical Practice (GCP), ethical and regulatory requirements and applicable Standard Operating Procedures (SOP). The Operations Manager also provides project mentorship/guidance to Project Managers (PM) and their teams, assisting in developing project knowledge and improving their execution. The Operations Manager will provide broad support to activities undertaken by PO leadership as required such as conducting external Project Reviews and providing advice to internal and external stakeholders on operational aspects of their studies. The Operations Manager will support the uptake of external projects by conducting the initial discussions, developing the budget and undertaking contract negotiations. 

Reporting Relationships

The Operations Manager reports to the Director, Global Project Operations.

The Operations Manager has both functional and line management responsibilities for assigned Project Managers (PMs) and may have direct or indirect line management responsibilities and/or functional responsibilities for Senior Clinical Research Associate (SCRAs), Clinical Research Associate (CRAs), Senior Project Officer (SPOs), and Project Officers (POs). The Operations Manager will work closely with the PO PM group to provide and develop project expertise to continuously improve delivery of projects. 

Duties and Key Responsibilities

Leadership/Coach

• Inspire PO staff in their role and responsibilities for project delivery and project team oversight, including providing technical guidance (where required), and being the point of issue of escalation for PO Team.
• Provide advice, coaching, mentorship, and training to develop and facilitate growth for team members.
• Develop and foster a collaborative team-work approach across regions and assigned projects, and the Project Operations team more broadly.
• Drive continuous improvement in delivery of projects in terms of its people, teams and processes including leadership and/or participation in relevant working groups.
• Actively engage with and contribute regionally and globally to other functional areas within CORE which include governance, Quality Assurance, Data Management, Biostatistics, Research Services and Research Training.
• Actively engage with implementation of PO and / or CORE strategic objectives and plans.
• Demonstrate and role model TGI’s core behaviours in all aspects of work and specifically in interactions with project team members and stakeholders.
• Actively engage with and participate in TGI activities e.g. UK and global updates, Wednesday seminars, #GeorgeTalks etc.
• Maintain confidentiality and ethical work practices at all times.
• Participate in objective setting, performance, and development planning.
• Ensure that Project Operation Team activities at TGI UK are accurately recorded in the Institute’s database. 

Clinical Trial Management & Technical Expertise

The Operations Manager is responsible for delivery of large and/or highly complex clinical trials within TGI from trial design/grant writing to closeout. The level of complexity may be determined by the research design, the size, budget and the locations/regions covered. The Operations Manager is also responsible to provide project management guidance and technical expertise. 

Project Development and Support

• Provide grant budget operational support as required e.g. budget development, proposal development and review (for grant submissions), protocol review.
• Ensure regular entry and updating of SPoT for project operations to ensure clean and accurate data of all projects and use of data for reporting.
• Ensure up to date risk identification, assessment and mitigation is entered into SPoT and regular review and escalation of risk.
• Lead any collaboration activities e.g. contract development with external parties.
• Undertake project reviews for internal and external projects.
• For external collaborations, lead/participate in discussions with stakeholders as introduced by the Executive Director and/or Director Global Project Operations.
• Provide advice and support for internal and external projects as requested by the Director Global Project Operations and/or where required by other PO team members.
• Report on project status and progress to the Director Global Project Operations as required.

Project Start-up

• Lead relevant project specific meetings.
• Establish and lead project team.
• Develop and/or lead development of the project plan and associated plans and other internal project management documents.
• Develop project budget.
• Lead development of project specific documents such as protocol and participant information forms as requested.
• Identify key stakeholders.
• Lead the feasibility planning, selection process and establishment of project sites.
• Identify project specific activities that need to be out-sourced and manage vendor selection and contracting.
• Oversee ethics applications and regulatory applications as applies.
• Manage site budget development and oversee sites contract negotiations.

Project Implementation

• Deliver project specific milestones and budgets, and continuously monitor project progress to these timelines and budgets, reporting to stakeholders as required.
• Manage all aspects of the project(s) including but not limited to:
  • Project risk and ensure risk reporting is maintained.
  • Data quality, accuracy, completeness and timeliness.
  • Complete and efficient resolution of data queries.
  • Accurate and detailed reports from monitoring visits are maintained.
  • Manage and supervise the monitoring visit schedules, and ensure carried out according to study design.
  • Review and sign-off the monitoring visit reports.
  • Ensure the study is conducted in accordance with study protocol and procedures manual, applicable regulatory requirements, local ethics committee requirements and ICH-GCP guidelines, if applicable.
  • Manage all documentation for the project (including but not limited to all GCP requirements (if applicable), contact details, signed contracts, serious adverse event reports and ethics committee reports).
  • Oversee the ongoing management of the participating sites to ensure adequate recruitment, data quality & timely CRF completion by investigators.
  • Participate in the scheduled project meetings or teleconferences with the staff in the organisation.
  • Ensure effective communication is maintained with all investigators, site staff, study staff and the operational team.
• Oversee the conduct of site monitoring and training, if required.
• Provide or contribute to progress reports for project originator and other stakeholders.
• Oversee all project administration e.g. study management committee meetings, project newsletters etc.
• Manage relationships with all key stakeholders including TGI management, TGI functional groups, committees, vendors, service providers, site staff and any others.

Project Close-out

• Work with the clinical team to ensure timely & successful completion of project.
• Manage data cleaning and audit processes, including communication with the statisticians and data managers.
• Finalise project finances and payments in accordance with contractual arrangements.
• Oversee all study closeout visits (as required):
  • Ensure final reconciliation of clinical supplies and ensure that all clinical supplies’ documentation is complete for the study.
  • Manage final archiving of study related documents.

Technical Expertise

• Subject matter expert in clinical trials/research project management; engendering knowledge sharing across the project operations platform globally.
• Provide technical advice and suggestions in project consultations and reviews.
• Review and /or contribute to the development of the TGI Project Operations SOPs.
• Support budget development and review for funding applications.
• Contribute to content and/or delivery of project management training within APO.
• Provide advice and support to groups outside of APO on project operations.

Compliance and Training

• Comply with all TGI policies.
• Mandatory attendance at all training considered essential for the role and as directed by management.
• Attend and actively participate in preparation and delivery of project management related training and workshops.
• Comply with all required project specific and TGI specific systems.
• Comply with all applicable regulations, guidelines, SOPs and project specific requirements. Complete and document all necessary training in the allocated system/form.  

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 TGI’s Performance Management and Development Policy.
• Demonstrate commitment to TGI’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.
• Contribute ideas and experiences so that improve processes, tools, systems and organisation. 

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.
• Ensure that team members participate in and comply with their assigned training schedule.
• Assist in the recruitment of the project staff. 

As a Team Leader

• 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. Applies to direct reports, indirect reports and functional reports.
• Actively identify and develop talent within the team.
• Manage performance issues within the team and direct reports, where necessary.
• Ensure project team members have access to necessary project specific training. 

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 TGI.
• Promote and contribute to a safe, secure environment for staff and visitors. 

Skills, Knowledge and Experience

Essential

Education

• Professional knowledge of clinical research management acquired through a degree or equivalent and supplemented by (a) specialist training to doctorate or equivalent level, or (b) management qualification, or (c) equivalent experience. 

Experience and Knowledge

• Experience of professional leadership and team building at an operational level.
• Experience of clinical research management at a senior level, to include extensive experience in the planning, coordination and conduct of clinical trials and other clinical research studies.
• Experience in the line management of research and research–related staff.
• Knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice.
• Knowledge of current national systems and structures for the funding and support of clinical research in the NHS.
• Development of grant applications according to national guidelines and standards.
• Experience of effective project management.
• Experience of successful financial management including understanding of FEC costing. 

Skills & Abilities

• Proven leadership skills.
• Ability to communicate highly complex, sensitive or contentious information both orally and in writing, both internally to colleagues and externally to a range of audiences, including large groups.
• Ability to prepare and deliver presentations and reports to a high standard.
• Proven interpersonal skills to work with clinical and management colleagues at all levels across a range of organisations.
• Strong problem-solving skills.
• Ability to plan, manage, adjust and deliver complex projects, involving multiple agencies and individuals and a broad range of activities to tight deadlines.
• Ability to work with minimal day-to-day supervision.
• Good IT skills, particularly in the use of Web applications and MS Office applications.
• Flexible approach to working and a desire to develop knowledge.
• Excellent attention to detail.
• Highly motivated, with the ability to influence and inspire others.
• 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.
• Ability to travel. 

Desirable

• Experience with managing decentralised Clinical Trials. 

Please note that job descriptions cannot be exhaustive, and the post-holder may be required to undertake other duties, which are broadly in line with the above key responsibilities. 

How to apply:

Please send your CV and cover letter explaining why you would be suited to, and successful in this role to Anna Willis, via the 'Apply' button above, by 5pm GMT on Thursday 07 March 2024.