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Clinical Trial Manager

1 month ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Summary

We are seeking a highly skilled Clinical Trial Manager to join our team at Bicycle Therapeutics. As a key member of our Clinical Operations group, you will play a critical role in planning, implementing, and overseeing our clinical trials.

Key Responsibilities
  • Lead cross-functional clinical study teams to ensure successful trial implementation and protocol execution
  • Manage and oversee activities at CROs and other clinical vendors, monitoring status and providing real-time updates to the program team
  • Ensure all study activities are completed in accordance with ICH GCP, health authority regulations, and company SOPs
  • Contribute to the writing and development of clinical documents, including protocols, informed consent forms, and study reports
  • Review and maintain the Trial Master File (TMF) and ensure that tracking tools are developed and maintained throughout the trials
  • Support clinical operations functions during audits and participate in the review and approval of clinical monitoring visit reports
  • Interface with internal functions to coordinate the exchange of information and materials to support clinical trials
Requirements
  • Familiarity with ICH, GCP, and FDA requirements for clinical trial management
  • Strong organizational and analytical skills, with the ability to work independently and collaboratively in a dynamic team environment
  • Excellent written and oral communication skills, with proficiency in Microsoft Office
  • Flexible approach to change and ability to adapt to new situations
What We Offer
  • A state-of-the-art campus environment with on-site amenities and a flexible working environment
  • A competitive reward package, including annual bonuses and employee recognition schemes
  • 28 days annual leave, plus bank holidays and the option to buy additional days
  • Employer contribution to pension, life assurance cover, and private medical insurance
  • Access to a company-subsidized gym membership and cycle-to-work scheme

Bicycle Therapeutics is committed to building a diverse workforce that reflects the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.