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Senior Clinical Trial Associate
2 months ago
Bicycle 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 maintaining the logistical aspects of our clinical study programs. This role will involve communicating effectively with internal and external study personnel, facilitating the activities associated with the successful clinical trial management and execution of our clinical programs.
Key Responsibilities:- Support the clinical study team(s) 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
- 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
- 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
Bicycle Therapeutics is an equal opportunities employer and welcomes applications from all qualified candidates. We offer a competitive reward package, including annual company bonus, employee recognition schemes, and a range of benefits.
