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Clinical Trial Operations Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

Job Summary

We are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team at Bicycle Therapeutics. As a key member of our team, you will be responsible for administering, coordinating, and maintaining the logistical aspects of our clinical study programs.

Key Responsibilities

  • Study Oversight
    • Support the clinical study team(s) with the oversight of Contract Research Organizations (CROs) and management of studies, including planning, execution, and close-out of clinical trials
    • Assist with management of study-related vendors
  • Document Management
    • Assist the Clinical Trial Manager (CTM) in preparing Protocols, Informed Consent Forms, Investigator Brochures, and other study documents, and track revisions
    • Support the CTMs in the set up and maintenance of the internal electronic filing systems (eTMF) compliant with regulations and in audit-ready state, as well as general study filing
  • Tracking and Reporting
    • Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
    • Perform lab sample tracking, utilizing the central lab database
    • Perform drug supply tracking and management
  • Regulatory Compliance
    • Review of data management aspects of clinical trials
    • Support clinical operations functions during audits (e.g., BIMO, FDA)
  • Communication and Collaboration
    • Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow-up items as requested
    • Participate in the review and finalization of study plans and circulate for approval
    • Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
  • Quality Control
    • Perform QC of electronic Trial Master Files
    • Fully understand the need for and importance of being inspection-ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps
  • Administrative Support
    • Accountable for ensuring that agendas for meetings are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings
    • Assist CRO with planning of Investigator Meetings and associated travel
    • Under the guidance and direction of the CTM, interface with other internal functions to coordinate relevant and timely exchange of information/materials to support clinical trials
    • Support invoice and budget activities for clinical trials
    • Facilitate review of clinical trial agreements such as contracts and licenses
    • Identifies potential risks from study and site perspective and works with the CTM to assist in proactively resolving issues with CROs
    • Participates in User Acceptance Testing (UAT) for Electronic Data Capture (EDC)/Integrated Randomization and Treatment (IRT)

Requirements

  • Essential
    • Bachelor's degree in scientific, biological, life sciences, or related field
    • Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
    • Strong organizational skills and enjoys working in a methodical way
    • Strong analytical and problem-solving skills
    • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
    • Attention to detail and quality
    • Excellent written and oral communication skills
    • Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
    • Flexible approach to change
  • Desirable
    • Early phase and/or Oncology experience

Additional Information

  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery
  • Flexible working environment
  • Competitive reward including annual company bonus
  • Employee recognition schemes
  • 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
  • Employer contribution to pension (employee does not have to contribute)
  • Life assurance cover 4x basic salary
  • Private Medical Insurance, including optical and dental cover
  • Enhanced parental leave policies
  • Group income protection
  • Employee assistance program
  • Health Cash Plan
  • Access to company-subsidized gym membership
  • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
  • Cycle to work scheme