Clinical Trial Associate
1 week ago
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 Clinical Trial Associate / Senior Clinical Trial Associate that will be responsible for administering, coordinating, and maintaining the logístical aspects of Bicycle’s clinical study programs. 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.
- Support the clinical study team(s) with the oversight of CROs and management of studies, including planning, execution, and close-out of clinical trials
- Assists 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**:
**Essential**:
- Prior experience or education 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
**Desirable**:
- Early phase and/or Oncology experience
Additional Information
- State-of-the-art campus environment with on campus restaurant and Montessori nursery
- Flexible working environment
- Competitive reward including annual company bonus
- Employee recognition schemes
- 28 days annual leave in addition to bank holidays + 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 pro
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