Current Openings

Clinical Endpoints Specialist

London
DEPARTMENT: CLINICAL
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – DIRECTOR OF CLINICAL OPERATIONS

Purpose of Job

Contribute to the execution of gene therapy projects by working with clinical and regulatory teams to ensure novel endpoints and assessments are appropriately validated and can be scaled up for use in multiple sites. They will partner with MeiraGTx project teams and management to effectively identify and resolve problems or concerns. 

Major Activities

  • Work closely with the clinical and regulatory teams to understand regulatory requirements for validating and implementing study endpoints
  • Work closely with clinical sites to manage the set up and installation of assessment devices
  • Co-ordinate the manufacturing components required to up-scale assessment capability to multiple sites
  • Ensure assessment capability is in place to coincide with study start up
  • Provide cost management for activities
  • Ensure activities are conducted in compliance with applicable regulations and Good Clinical Practice
  • Understand the technical requirements for the assessments, their mode of operation, and how that translates to clinical need
  • Train staff and troubleshoot on the assessment capability
  • Develop protocols to ensure reproducibility and reliability of assessments across sites
  • Co-ordinate endpoint adjudication activities where required
  • Compile and maintain project-specific status reports;
  • Create and maintain project timelines

Key Performance Indicators

  • Ensuring sites are able to participate fully in clinical studies with respect to their ability to assess endpoints
  • Ensuring all necessary documentation and results are available to support licensing applications with respect to study endpoints
  • Ensuring senior management tracking systems for trial related paperwork remain up to date

Key Job Competencies

  • Understanding of clinical trial processes and needs
  • Excellent transferrable skills
  • IT literacy, particularly in Word, Excel and PowerPoint
  • Knowledge of ICH GCP

Job Responsibilities

  • 0 direct reports
  • Financial authority for submitting clinical team expenses and raising Purchase Orders on request

Job Background

  • University degree or equivalent in sciences, engineering, nursing or pharmacy or related field
  • Previous experience of working in Clinical Research or the Pharmaceutical Industry
  • Knowledge of the Industry/Clinical trial process and drug development
  • Experience of working with industry regulators (MHRA/FDA)
  • Experience of using the DIA Trial Master File Reference Model

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