Senior Clinical Trial Associate

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Title: Senior Clinical Trial Associate

Bicycle Therapeutics is seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team. 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:
  • Support the clinical study team(s) with the oversight of CROs and management of studies, including planning, execution, and close-out of clinical trials
  • Assist with management of study-related vendors
  • 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
  • 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
  • Review of data management aspects of clinical trials
  • Support clinical operations functions during audits (e.g. BIMO, FDA)
  • 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
  • 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
  • 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 UAT for EDC/IRT
Qualifications:
  • 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

Bicycle Therapeutics is an equal opportunities employer and welcomes applications from all qualified candidates. We offer a competitive reward package, including annual company bonus, employee recognition schemes, and a range of benefits. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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