Senior Clinical Trial Associate

2 days 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 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
  • Prepare Protocols, Informed Consent Forms, Investigator Brochures, and other study documents, and track revisions
  • Set up and maintain internal electronic filing systems (eTMF) 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, utilizing the central lab database
  • Perform drug supply tracking and management
  • Review 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
  • Participate in the review and finalization of study plans
  • Day-to-day contact with counterpart at CRO; identify potential issues or problems with the sites and communicate/escalate to senior Clinical Operations staff
  • Perform QC of electronic Trial Master Files
  • Ensure 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
  • 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 team to assist in proactively resolving issues with CROs
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
Additional Information:
  • Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve
  • We recognize that diverse and inclusive teams build a stronger and more innovative company

  • Senior Clinical Trial Associate

    21 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our Clinical Operations team.Job Summary:The Senior Clinical Trial Associate will be responsible for administering, coordinating, and...

  • Senior Clinical Trial Associate

    20 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our Clinical Operations team.Job Summary:The Senior Clinical Trial Associate will be responsible for administering, coordinating, and...

  • Senior Clinical Trial Associate

    23 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our Clinical Operations team.Job Summary:The Senior Clinical Trial Associate will be responsible for administering, coordinating, and...

  • Senior Clinical Trial Associate

    24 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our Clinical Operations team.Job Summary:The Senior Clinical Trial Associate will be responsible for administering, coordinating, and...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team.Job SummaryThe Senior Clinical Trial Associate will be responsible for administering, coordinating, and maintaining...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team.Job SummaryThe Senior Clinical Trial Associate will be responsible for administering, coordinating, and maintaining...

  • Senior Clinical Trial Associate

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateWe 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 overseeing the logistical aspects of our clinical study programs, ensuring seamless execution and compliance with...

  • Senior Clinical Trial Associate

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateWe 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 overseeing the logistical aspects of our clinical study programs, ensuring seamless execution and compliance with...

  • Senior Clinical Trial Associate

    7 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.Key ResponsibilitiesSupport the clinical study team(s) with the oversight of CROs and management of studies, including...

  • Senior Clinical Trial Associate

    9 hours ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team.Key ResponsibilitiesSupport the clinical study team(s) with the oversight of CROs and management of studies, including...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management and execution of our clinical programs.Key Responsibilities:Support the clinical...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management and execution of our clinical programs.Key Responsibilities:Support the clinical...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team and contribute to the success of our clinical study programs.Key Responsibilities:Support the...

  • Clinical Trial Associate

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Senior Clinical Trial Associate to join our team and contribute to the success of our clinical study programs.Key Responsibilities:Support the...

  • Clinical Trial Associate

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key Responsibilities:Administer and coordinate...

  • Clinical Trial Associate

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key Responsibilities:Administer and coordinate...

  • Clinical Trial Associate

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key Responsibilities:Administer and coordinate...

  • Clinical Trial Associate

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Senior Clinical Trial AssociateBicycle Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for underserved diseases. We are seeking a Senior Clinical Trial Associate to join our team and contribute to the successful management of our clinical study programs.Key Responsibilities:Administer and coordinate...