Senior Clinical Trial Associate

2 months ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
About the Role

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
  • 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 the management of study-related vendors and ensure compliance with regulatory requirements.
  • Collaborate with Clinical Trial Managers (CTMs) in preparing study documents, such as protocols, informed consent forms, and investigator brochures, and track revisions.
  • Support the CTMs in the set up and maintenance of electronic Trial Master Files (eTMFs) compliant with regulations and in audit-ready state.
  • Develop and maintain tracking tools throughout the trials for the Clinical Operations teams.
  • Perform lab sample tracking and drug supply management using central lab databases.
  • Review data management aspects of clinical trials and ensure compliance with regulatory requirements.
  • Support clinical operations functions during audits and inspections.
  • Participate in the review and approval of clinical monitoring visit reports and track outstanding follow-up items.
  • Participate in the review and finalization of study plans and circulate for approval.
  • Establish and maintain effective communication with CROs and internal stakeholders.
  • Perform quality control of electronic Trial Master Files.
  • Ensure that agendas for meetings are clear and distributed in advance, and take comprehensive and precise minutes for internal and external meetings.
  • Assist CROs with planning of Investigator Meetings and associated travel.
  • 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.
  • Identify potential risks from study and site perspective and work with the CTM to assist in proactively resolving issues with CROs.
Requirements
  • Bachelor's degree in a scientific, biological, life sciences, or related field.
  • Familiarity with ICG, GCP, and FDA requirements for clinical trial management.
  • Strong organizational skills and ability to work methodically.
  • 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.
What We Offer
  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment.
  • Competitive rewards, including annual company bonus.
  • Employee recognition schemes.
  • 28 days annual leave in addition to bank holidays, plus 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.

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