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Clinical Trial Manager

3 months ago

London, UK, United Kingdom Clerkenwell Health Full time

Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials using its collaborative Contract Research Organisation, extensive Site Network, and leading Therapy Development Programme. Clerkenwell Heath specialises in the supporting the Mental Health and CNS space with a focus on Psychedelic drug development.


The post holder will have a leading role in planning, coordinating and managing operational activities including regulatory, trial and vendor management as a senior member of the CRO team. They will have specialist knowledge of applicable regulations, nationally and internationally as appropriate, and be able to provide regulatory and/or governance advice where required.


The postholder will demonstrate strategic, tactical and operational management skills in the planning and execution of trials, and will have excellent communication and presentation skills, together with the ability to organise and motivate others. The postholder will also be responsible for the overall management and oversight of the study, in compliance with the study protocol and international standards of Good Clinical Practice (GCP). The role requires an understanding of, and experience in, research management and governance which may have been gained as part of a CRO, Sponsor organisation or academic setting.


Job Description


Under the overall direction of the Head of CRO Services, the post holder will be responsible, alongside the other senior staff, for ensuring strong and effective working links between Clerkenwell Heath and all associated organisations and sponsors. They will act as the main point of contact and project lead for Sponsors, clients and other relevant external organisations and groups as required. The post holder will be essential in ensuring the effective development, conduct, management and delivery of Clerkenwell Health CRO trials. They will also collaborate with other appropriate CROs, academics and commercial organisations as needed.


Main duties and accountabilities:


Trial Management


  1. Understanding the requirements of the various ethical and regulatory bodies, agencies and frameworks, guiding the trial in conforming to those requirements and any necessary audit processes.
  2.  Preparing trial materials and trial applications, whilst establishing procedures to ensure adherence to trial protocols and administrative requirements.
  3. Leading on the creation and maintenance of all study files, including the trial master file, and oversight of Investigator site files.
  4. Coordinating applications, and amendments as applicable, to ethical and regulatory bodies.
  5. Defining the trial and site feasibility criteria and content of site selection and initiation visits.
  6. Analysing reports from trial monitoring visits, defining and implementing recovery plans as required and communicating issues arising from monitoring visits with clients.
  7.  Establishes overall project plan by defining key milestones, risks and mitigations and liaises with study sites and other members of trial team to ensure the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
  8. Preparing trial progress and monitoring reports for appropriate Data Monitoring Committees, as applicable, ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and ethical requirements, as applicable.


Finance and General Management 


  1. Contribute to the management, monitoring, control, and reporting of trial budgets, working closely with the Functional Heads and external organisations.
  2. ​Leads on the vendor selection process, liaising with the Quality Assurance team to follow internal risk assessment and due diligence processes. Oversee vendor management, escalating performance and delivery risks to the Head of CRO as required.​


Information Performance


  1. Leads on the production of key CRO documents, plans and reports as required and in conjunction with the Functional Heads. These may include the production of presentations, including metrics, financial plans and annual reports.
  2. Ensure that information is disseminated across CH as appropriate, ensure that information is uploaded as required onto local and national databases in a timely and accurate way, and generally ensure that all CRO information is managed to the highest operational and regulatory standards.


Quality Assurance


  1. Support the activities of the Quality Assurance team who are responsible for the implementation of the Quality Management System (QMS) across the trial portfolio.
  2. Contribute to the planning and conduct of trial and systems audit activity.
  3. Escalate of trial related issues to SMT as required.
  4. Assist with the preparation and conduct for any GCP inspection or 3rd party audit within the CRO.
  5. Support the review of CRO systems and processes to ensure continued compliance with relevant legislation.


Attainments/Qualifications

  • First degree/postgraduate qualification/professional qualification or equivalent plus extensive relevant experience.
  • Formal training in Good Clinical Practice (GCP)


Skills and Understanding

  • Strong knowledge and in-depth understanding of clinical trials management, including Clinical Trials of Investigational Medical Products (CTIMPs), and a track-record of successful delivery of research studies.
  • Strong skills in team leadership and motivating staff.
  • Demonstrable skills in project management.
  • In-depth knowledge of the principles of GCP, the EU Clinical Trials Directive and related UK Clinical Trials regulations, and the UK Policy Framework for Health and Social Care Research.
  • 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


Prior Experience

  • ​​Significant experience in the management of clinical trials, ​including Clinical Trials of​​
  • ​​Investigational Products (CTIMPs) ​at project management level, and of working according to Good Clinical Practice (GCP).
  • Experience of writing trial documentation, including protocols, ICFs and SOPs.
  • ​​Experience of making applications to regulatory bodies (MHRA) and to research ethical committees via IRAS​

​​

Behavioural Characteristics

  • Excellent written and verbal communication skills.
  • Able to form positive professional relationships and collaborate with stakeholders.
  • Able to balance the pressures of research, administrative demands and competing deadlines.
  • Able to proactively assume responsibility and make decisions impacting the course of a project.
  • Commitment to ongoing organisational innovation that includes personal development and training of others.


Circumstances

  • Ability to meet the hybrid working needs of the post