Job summary
We are looking for an experienced Clinical Trials Manager to oversee and
coordinate ongoing clinical trials in the Allergy department, and take particular
responsibility for the GRADUATE hay fever trial - https://www.hayfeverstudy.org.uk/ -
keeping it on course while the current postholder is on parental leave.
This is a great opportunity to be involved in this 4-year study,
currently in its 3rd year. It is an Investigator-led trial of hay fever
treatments, part of the Immune Tolerance Network and funded by NIAID, and based
within an NHS site. You would be working with a well-established and
experienced clinical and laboratory team, and responsible for continuing the
smooth running of this important trial. At this stage of the study, communication
with and retention of participants will be important, as will maintaining close
relationships with the Sponsor, NHS Trust and the teams involved.
Main duties of the job
- You will take the lead in coordinating and managing the GRADUATE trial, including planning and coordinating clinical and data management activities
- You will be responsible for maintaining GCP and regulatory oversight for the study, ensuring trial documentation is maintained appropriately
- You will take an active role in providing management support to other ongoing studies in the department
- You will have line management responsibility for the Assistant Clinical Trials Manager, supervising and supporting their workload and priorities, as well as supporting the clinical team with the same and ensuring optimal support for the studies
- You will lead on quality control measures and internal audit
- You will work with the College administrative and finance teams to oversee the budget, ensure spend is in line with funder rules and invoicing on the study is timely
- You will lead on reporting to and liaising effectively with the Sponsor and the CRO, as well as NHS colleagues (e.g. CTU, Pharmacy, Research Office)
- You will coordinate and arrange honorary contracts for department visitors, and support with travel and event arrangements and expenses
- You will act up or down as required for best success of the project
About us
This post is offered full time for 7 months provisionally, to cover
parental leave based at Royal Brompton Hospital. Part-time/flexible working
will be considered.
Candidates
will need to complete the online application to be considered for this role.
Should you have any questions or want to discuss the role, please
contact: Lisa Curry l.curry@imperial.ac.uk
The role is based in the Allergy Department of Royal Brompton Hospital,
Fulham Wing and, due to the clinical nature of the study activities, it is required
to be site-based.
As this post is exempt from the
Rehabilitation of Offenders Act 1974, a satisfactory Disclosure and Barring
Service (DBS) check, at the appropriate level, will be required for the
successful candidate.
Job description
Job responsibilities
An experienced
Trial Manager is required to manage and co-ordinate the Immune Tolerance
Network NIAID-funded GRADUATE Trial within Allergy and Clinical Immunology (Jan
2020-March 2025) under the line management of the Principle Investigator and
Protocol Chair Professor Stephen Durham and in partnership with the Immune
Tolerance Network Clinical Operations Team, based at University of California
in San Francisco.
GRADUATE is a
single-centre double-blind, double-dummy placebo-controlled trial (n=108). The
primary objective of this study is to test whether, in patients with
moderate-severe hay fever, 24 months of daily sublingual grass pollen tablet
immunotherapy in combination with a subcutaneous immune modifier administered
two-weekly is able to induce long-term tolerance to grass pollen and prolonged
clinical benefit at 36 months, 12 months after discontinuation of treatment.
Secondly to evaluate the safety and tolerability of the combination compared to
sublingual grass tablet immunotherapy alone. Thirdly to explore the
underlying mechanisms of immune tolerance with
the combination compared to sublingual immunotherapy alone.
To also manage and support other ongoing
clinical trials in the department.
Job description
Job responsibilities
An experienced
Trial Manager is required to manage and co-ordinate the Immune Tolerance
Network NIAID-funded GRADUATE Trial within Allergy and Clinical Immunology (Jan
2020-March 2025) under the line management of the Principle Investigator and
Protocol Chair Professor Stephen Durham and in partnership with the Immune
Tolerance Network Clinical Operations Team, based at University of California
in San Francisco.
GRADUATE is a
single-centre double-blind, double-dummy placebo-controlled trial (n=108). The
primary objective of this study is to test whether, in patients with
moderate-severe hay fever, 24 months of daily sublingual grass pollen tablet
immunotherapy in combination with a subcutaneous immune modifier administered
two-weekly is able to induce long-term tolerance to grass pollen and prolonged
clinical benefit at 36 months, 12 months after discontinuation of treatment.
Secondly to evaluate the safety and tolerability of the combination compared to
sublingual grass tablet immunotherapy alone. Thirdly to explore the
underlying mechanisms of immune tolerance with
the combination compared to sublingual immunotherapy alone.
To also manage and support other ongoing
clinical trials in the department.
Person Specification
Experience
Essential
- Experience of working on randomised, clinical trials of an investigational medicinal product (CTIMP).
- Extensive experience in clinical trial management.
- Evidence of preparing and submitting regulatory and ethics submissions, writing or
- amending protocols, Patient Information Sheets (PIS), Case Report Forms (CRFs) and other relevant trial management documentation.
- Experience of managing budgets and financial processing, including purchase order and expense claims.
- Experience of costing new projects.
- Experience of working with large sets of data.
- Experience of managing and developing staff.
- Experience of working within the NHS, and in clinical academic research setting.
Desirable
- A background in allergy and clinical immunology with expertise in clinical trials of allergen Immunotherapy for allergic diseases
- Evidence of experience using an electronic CRF.
- Previous experience working in the fields of allergy and clinical immunology.
- Experience of working with an international Sponsor.
Qualifications
Essential
- First degree (BSc) or equivalent qualification in the life sciences
- Masters, doctorate, or equivalent experience, which includes clinical trial methodology
Person Specification
Experience
Essential
- Experience of working on randomised, clinical trials of an investigational medicinal product (CTIMP).
- Extensive experience in clinical trial management.
- Evidence of preparing and submitting regulatory and ethics submissions, writing or
- amending protocols, Patient Information Sheets (PIS), Case Report Forms (CRFs) and other relevant trial management documentation.
- Experience of managing budgets and financial processing, including purchase order and expense claims.
- Experience of costing new projects.
- Experience of working with large sets of data.
- Experience of managing and developing staff.
- Experience of working within the NHS, and in clinical academic research setting.
Desirable
- A background in allergy and clinical immunology with expertise in clinical trials of allergen Immunotherapy for allergic diseases
- Evidence of experience using an electronic CRF.
- Previous experience working in the fields of allergy and clinical immunology.
- Experience of working with an international Sponsor.
Qualifications
Essential
- First degree (BSc) or equivalent qualification in the life sciences
- Masters, doctorate, or equivalent experience, which includes clinical trial methodology
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
