Clinical Project Manager (University College London)

About us The mission of the UCL GOS Institute of Child Health is to improve the health and well-being of children, and the adults they will become, through world-class research, education and public engagement. The UCL GOS ICH, together with its clinical partner Great Ormond Street Hospital for Children, forms the largest concentration of children’s health research outside North America. GOS ICH’s activities include active engagement with children and families, to ensure that our work is relevant and appropriate to their needs. GOS ICH generates the funding for our research by setting out our proposals in high quality applications to public, charitable and industrial funding bodies and disseminates the results of our research by publication in the medical and scientific literature, to clinicians, policy makers and the wider public. The Institute offers world-class education and training across a wide range of teaching and life learning programmes which address the needs of students and professional groups who are interested in and undertaking work relevant to child health. GOS ICH holds an Athena SWAN Charter Gold Award. About the role Applications are invited for a Clinical Project Manager to join the Molecular and Cellular Immunology Section at UCL Great Ormond Street Institute of Child Health (UCL GOSICH). This position is to provide clinical trial support to the internationally renowned advanced therapies group at the Institute of Child Health. It will provide an opportunity to work with cutting edge clinical researchers and interact across inter-disciplinary groups. The gene and cell therapy group are involved in a portfolio of trials involving rare diseases, strategies to improve immune responses to infection, leukaemia after haematopoietic stem cell transplantation, somatic gene therapy for primary immunodeficiencies, HIV, inherited skin and metabolic disorders. You will be responsible for the set-up and management of a large number of phase I/II gene and cell therapy clinical trials, including (but not limited to) writing/reviewing all essential documents, preparing & submitting CTAs/amendments to MHRA, ethics committees and local R&D offices. You will also be responsible for writing annual progress reports, DSURs and clinical study reports. You will ensure all clinical trials are conducted in line with the protocols, GCP and the EU directives. Where required, you will also coordinate preparation and submission of Orphan Drug Designation Applications and requests for protocol assistance, scientific advice to the regulatory agency. The post is initially funded for 12 months in the first instance. About you Applicants must have a Bachelors degree in an appropriate speciality and previous experience in clinical trials management, including preparation and submission of MHRA/ethics applications and amendments. Expertise in gene and cell therapy, molecular biology or immunology, experience working in clinical trials of ATIMPs experience are desirable but not essential What we offer As well as the exciting opportunities this role presents, we also offer some great benefits some of which are below: • 41 Days holiday (27 days annual leave 8 bank holiday and 6 closure days) • Additional 5 days’ annual leave purchase scheme • Defined benefit career average revalued earnings pension scheme (CARE) • Cycle to work scheme and season ticket loan • Immigration loan • Relocation scheme for certain posts • On-Site nursery • On-site gym • Enhanced maternity, paternity and adoption pay • Employee assistance programme: Staff Support Service • Discounted medical insurance Visit https://www.ucl.ac.uk/work-at-ucl/reward-and-benefits to find out more. Our commitment to Equality, Diversity and Inclusion As London’s Global University, we know diversity fosters creativity and innovation, and we want our community to represent the diversity of the world’s talent. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are likely to be underrepresented in UCL’s workforce. These include people from Black, Asian and ethnic minority backgrounds; disabled people; LGBTQI+ people; and for our Grade 9 and 10 roles, women. You can read more about our commitment to Equality, Diversity and Inclusion here : https://www.ucl.ac.uk/equality-diversity-inclusion/ If you have any queries regarding the application process, please contact Madhur Sharma on ich.hr@ucl.ac.uk quoting job reference If you apply for this position please say you saw it on Adminoxy

About us

The mission of the UCL GOS Institute of Child Health is to improve the health and well-being of children, and the adults they will become, through world-class research, education and public engagement. The UCL GOS ICH, together with its clinical partner Great Ormond Street Hospital for Children, forms the largest concentration of children’s health research outside North America. GOS ICH’s activities include active engagement with children and families, to ensure that our work is relevant and appropriate to their needs. GOS ICH generates the funding for our research by setting out our proposals in high quality applications to public, charitable and industrial funding bodies and disseminates the results of our research by publication in the medical and scientific literature, to clinicians, policy makers and the wider public. The Institute offers world-class education and training across a wide range of teaching and life learning programmes which address the needs of students and professional groups who are interested in and undertaking work relevant to child health. GOS ICH holds an Athena SWAN Charter Gold Award.

About the role

Applications are invited for a Clinical Project Manager to join the Molecular and Cellular Immunology Section at UCL Great Ormond Street Institute of Child Health (UCL GOSICH). This position is to provide clinical trial support to the internationally renowned advanced therapies group at the Institute of Child Health. It will provide an opportunity to work with cutting edge clinical researchers and interact across inter-disciplinary groups. The gene and cell therapy group are involved in a portfolio of trials involving rare diseases, strategies to improve immune responses to infection, leukaemia after haematopoietic stem cell transplantation, somatic gene therapy for primary immunodeficiencies, HIV, inherited skin and metabolic disorders. You will be responsible for the set-up and management of a large number of phase I/II gene and cell therapy clinical trials, including (but not limited to) writing/reviewing all essential documents, preparing & submitting CTAs/amendments to MHRA, ethics committees and local R&D offices. You will also be responsible for writing annual progress reports, DSURs and clinical study reports. You will ensure all clinical trials are conducted in line with the protocols, GCP and the EU directives. Where required, you will also coordinate preparation and submission of Orphan Drug Designation Applications and requests for protocol assistance, scientific advice to the regulatory agency. The post is initially funded for 12 months in the first instance.

About you

Applicants must have a Bachelors degree in an appropriate speciality and previous experience in clinical trials management, including preparation and submission of MHRA/ethics applications and amendments. Expertise in gene and cell therapy, molecular biology or immunology, experience working in clinical trials of ATIMPs experience are desirable but not essential

What we offer

As well as the exciting opportunities this role presents, we also offer some great benefits some of which are below: • 41 Days holiday (27 days annual leave 8 bank holiday and 6 closure days) • Additional 5 days’ annual leave purchase scheme • Defined benefit career average revalued earnings pension scheme (CARE) • Cycle to work scheme and season ticket loan • Immigration loan • Relocation scheme for certain posts • On-Site nursery • On-site gym • Enhanced maternity, paternity and adoption pay • Employee assistance programme: Staff Support Service • Discounted medical insurance Visit https://www.ucl.ac.uk/work-at-ucl/reward-and-benefits to find out more.

Our commitment to Equality, Diversity and Inclusion

As London’s Global University, we know diversity fosters creativity and innovation, and we want our community to represent the diversity of the world’s talent. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are likely to be underrepresented in UCL’s workforce. These include people from Black, Asian and ethnic minority backgrounds; disabled people; LGBTQI+ people; and for our Grade 9 and 10 roles, women. You can read more about our commitment to Equality, Diversity and Inclusion here : https://www.ucl.ac.uk/equality-diversity-inclusion/ If you have any queries regarding the application process, please contact Madhur Sharma on ich.hr@ucl.ac.uk quoting job reference

If you apply for this position please say you saw it on Adminoxy

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