Clinical Trials Unit Manager, Global Health Trials Unit

1 month ago

Liverpool, United Kingdom LSTM Full time

An exciting opportunity has arisen for an experienced Operations Manager for the Global Health Trials Unit (GHTU) to work within LSTM. As the first institution of its kind in the world, dedicated to education and research in tropical diseases, it's an exciting time to join us as we celebrate our 125th anniversary year in 2023.

Background

The GHTU is an academic trials unit with staff expertise and infrastructure to plan, support and manage phase I, II and III randomized-controlled trials and high-quality observational studies. The expertise and focus of the unit are studies of high-burden and priority diseases of national and international importance in low and middle-income countries. The unit functions through three complementary strands: data management, trial management and statistical support.

Demand for partnership with the unit has been rising year on year for the last 5 years as clinical trials are an area of continuing major expansion at LSTM and as pragmatic trials become integrated in health systems research funding calls. Few institutions bring together staff experienced in conducting high quality robust trials in LMICs at low cost. The GHTU has a portfolio of approximately 30 projects with a range of investigators that use varying levels of service and collaboration.

We envisage there will be the opportunity for the role holder to progress to HERA Grade 9 after a period 2 years, as the GHTU develops capacity and capability, subject to LSTM regrade process.

The Role

This strategic post will lead the day-to-day operations of the GHTU, responsible for providing oversight of operational activities including trial, data and business management. The successful candidate will develop and manage a sustainable business model for the GHTU; monitoring budgets and workplans and implementing strategies for continuous quality improvement across a global portfolio of clinical trials. 

As a proven leader you will be the focal person at the GHTU to engage LSTM groups and external partners and will be responsible for the overall promotion and management of the Unit. Together with the Director you will promote the GHTU as a centre of excellence in global health trials, ensuring high quality standards and a viable business model for its sustainable growth.

Key deliverables will include, but not be limited to:

Strategic duties 

Contribute to the development of a sustainable strategy for the GHTU as a critical part of LSTM’s overall strategic plan. Implement and manage the strategic business plan for the GHTU Provide effective leadership and management of individuals, groups and activities in the GHTU Implement robust and transparent governance structures for GHTU

Business Management 

Plan the work of the multi-disciplinary team within GHTU ensuring workplans and deliverables are achieved Provide high-level trial management input, supporting recruitment teams and clinical trial project managers and coordinators on activities concerned with the GHTU. Organise the recruitment, retention, training, appraisal and supervision of all staff within the GHTU

Financial management

Responsible for managing the Unit’s budgets, and maintenance of accounts Ensure funders’ procurement processes are adhered to and in compliance with contractual requirements. Ensure timely drafting and submission of all reporting commitments to the relevant funders Co-ordinate GHTU responses to support submission of funding applications and documenting the GHTU budget requirements 

Regulatory compliance/Quality Assurance

Ensure GHTU Standard Operating Procedures are developed, maintained and updated, Maintain excellent relationships with LSTM’s Research Governance and scientific computing units to ensure GHTU’s work is conducted to the appropriate regulatory standards Oversee the maintenance of relevant documentation systems for all trials Ensure the GHTU operates to high scientific, ethical and governance standards

Business Development

Build and maintain a network of internal and external contacts relevant to GHTU’s activities in global clinical trials Engage with LSTM research groups to identify opportunities for new work Take initiative to develop and embed new strategies for business development for GHTU

We are seeking a candidate with exceptional communication and organisation skills to manage the financial processes of the Unit, monitor the progress of projects, the delivery of milestones and reports, and the performance management of a highly skilled multidisciplinary team. You will have the skills to negotiate with confidence, tact and diplomacy across a diverse range of partners, organisations and cultures.

The ideal candidate will demonstrate:

Proven experience of management of clinical trials Experience of recruiting, managing and developing a multi-disciplinary team Experience of managing and coordinating multiple budgets and activities including costing of randomised controlled trials or other large studies Ability to develop and maintain partnerships working both internally and externally Knowledge of all aspects of trial management including Clinical Trials of Investigational Medicinal Products (CTIMPs) and Good Clinical Practice

Additional benefits of joining LSTM:

Generous occupational pension schemes Government backed “cycle to work” scheme. Affiliated, discounted staff membership to the University of Liverpool Sports Centre Plus, a host of additional family friendly policies

Closing date: 31st August 2023

Date of interviews: w/c 4thSeptember 2023

Application process: to apply for this role, please submit your CV via the ‘apply’ link below. Due to the volume of applications we receive, we sometimes close our vacancies early. It is therefore advisable to apply as early as possible if you would like to be considered for a role.

Inclusion is central to our values at LSTM

We seek to attract and recruit people who reflect the diversity across our communities, regardless of sexual orientation, gender identity, ethnicity, nationality, faith or belief, social background, age and disability.

We strongly encourage applications from women, disabled and Black, Asian and Minority Ethnic (BAME) candidates and value the positive impact that diversity brings to our teams. 

We welcome conversations about flexible working; and applications from those returning to employment after a break from their careers. 

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