Clinical Trial Manager

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 jobThe 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.About usGOSH 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.Job descriptionJob responsibilitiesThe 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.Person SpecificationGOSH Culture and ValuesEssential
GOSH Always Values
Academic/Professional qualification/TrainingEssential
Degree in a life Sciences discipline or postgraduate qualification in a life sciences discipline ICH-GCP certification
Experience/KnowledgeEssential
Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or a university. Either practical experience of monitoring clinical trial activity or practical experience of the research process or direct involvement in the management / administration of clinical trials Clinical trial management experience Excellent knowledge of ICH GCP, EU clinical trials legislation and UK clinical trial regulations Good understanding of the Department of Health's Research Governance Framework and the HRA Approval process Knowledge of clinical trials in all phases Excellent knowledge in the working of Clinical Trials of Investigational Products Experience of managing and implementing quality control and quality assurance systems Experience in hosting or participating in regulatory inspections (MHRA, FDA, etc.)
Desirable
Understanding of the NHS R& D structure and functions
Skills/AbilitiesEssential
Ability to evaluate risks inherent in clinical trials and decide those which should be prioritised to ensure that risks are properly managed Excellent communication and good presentation skills Excellent report writing skills Ability to analyse and rationalise research information and ability to take decisions in complex situations Ability to coach and mentor senior academic staff including consultants Ability to prioritise workload and plan ahead Excellent planning, organisation and negotiation skills Ability to provide Pharmacovigilance, GCP advice to a high standard Ability to work accurately, with strong attention to detail Ability to work both autonomously and as part of a diverse team. Self-motivated, with ability to work on own initiative, making decisions where appropriate Flexible working approach and adaptable to change. Commitment to team-working Ability to acquire new knowledge and skills Meticulous attention to details Leadership qualities Experience of staff supervision or line management Ability to coordinate and oversee the working practices of junior team members
Desirable
Understanding of financial concepts and needs relating to research funding, particularly clinical trials
Employer detailsEmployer nameGreat Ormond Street Hospital for Children NHS Foundation TrustAddressJoint R& D Office for GOSH/ICH 30 Guilford Street London WC1N 1EHAny attachments will be accessible after you click to apply. 271-RI-6124919
#J-18808-Ljbffr