Senior Clinical Trial Manager

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.  
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together. 

Job Description

We are looking for a Senior Clinical Trial Manager that will support the team in planning, implementation and oversight of Bicycle’s clinical trials. In this role, they will be responsible for communicating effectively with internal and external study personnel and in facilitating the activities associated with the successful clinical trial management and execution of Bicycle’s clinical programs.

The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations.

• Lead the cross functional clinical study team(s) to ensure successful clinical trial implementation and protocol execution including planning, execution, and close-out
• Manage and oversee activities at the CRO and other clinical vendors; monitor status and provide real-time updates to program team; facilitate communication between bicycle and the Clinical CRO
• Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
• Responsible for ongoing study communication and escalation of study-related issues as required
• Contribute to the writing and development of clinical documents such as Protocols, Informed Consent Forms, Investigator Brochures, project plans, pharmacy manuals, study reports and annual reports
• Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
• Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
• 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 CTA
• 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
• Fully understand the need for and importance of being inspection ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps
• 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
• Identifies potential risks from study and site perspective and works with the team to assist in proactively resolving issues with CROs
• Participates in UAT for EDC/IRT
• May perform periodic visits to sites and/or CRO to assess progress of studies/protocol compliance

Qualifications

Essential:  

• Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
• Early phase and/or Oncology experience 
• 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

• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy