Senior Clinical Trial Associate

5 days 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
  • Vendor Management
    • Assist with management of study-related vendors
  • Document Preparation
    • Assist the Clinical Trial Manager (CTM) in preparing Protocols, Informed Consent Forms, Investigator Brochures, and other study documents, and track revisions
  • Electronic Filing Systems
    • 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
  • Data Management
    • Review of data management aspects of clinical trials
  • Audit Support
    • 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
  • Regulatory Compliance
    • 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
  • Communication and Coordination
    • 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
  • Risk Management
    • Identifies potential risks from study and site perspective and works with the CTM to assist in proactively resolving issues with CROs
  • System Testing
    • Participates in UAT for EDC/IRT

Qualifications

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

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