Job overview
We are looking to recruit a Clinical Trial Manager for the R&D Office in the Division of Research & Innovation at Great Ormond Street Hospital for Children NHS Foundation Trust. The Trial Manager will be responsible for managing Trust sponsored clinical trials from initial concept to successful completion.
The main roles of the post are to coordinate the production and delivery of ICH-GCP compliant research protocols to high scientific and clinical standards. The studies vary from gene and cellular therapy trials to drug related trials from a range of clinical and academic specialties. The trial manager will be assigned to manage a personal portfolio of studies. This will involve work to address resource funding, external and internal approval, sponsorship requirements, regulatory submissions, completing risk assessments, conducting trial initiations, trial monitoring and reporting and keeping up to date with changes in regulatory requirements related to clinical trials.
Main duties of the job
The successful applicant will have a degree in a relevant subject or significant relevant experience, in clinical methodology and a strong technical medical writing, editorial and critical proof-reading skills are essential coupled with the ability to negotiate with professionals at all levels. A proven track record as a successful clinical researcher, ideally gained in the phase I/II clinical setting is desirable, with a strong working knowledge of Good Clinical Practice and navigating the various UK clinical research governance frameworks and including an understanding of the HRA Approval process. You will need to be flexible, motivated, confident and creative and bring a new dimension to dealing with the management of clinical trials.
To ensure that Trust is in compliance with the EU Clinical Trials Directive and UK legislation (Medicines for Human Use Regulations) implementing Good Clinical Practice for CTIMPs. Please refer to the job description for more information pertaining to the role.
Working for our organisation
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.
We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.
We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.
We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.
We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women’s staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust’s mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Detailed job description and main responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
