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Senior Clinical Trial Associate
1 month ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob 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 Operations Specialist
2 months ago
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.
The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials.
The Senior Clinical Trial Associate will be responsible for administering, coordinating, and maintaining the logistical aspects of Bicycle's clinical study programs.
Key Responsibilities:- Study Oversight: Support the clinical study team(s) with the oversight of Contract Research Organizations (CROs) and management of studies, including planning, execution, and close-out of clinical trials.
- Vendor Management: Assist with management of study-related vendors.
- Document Preparation: Assist the Clinical Trial Manager (CTM) in preparing Protocols, Informed Consent Forms, Investigator Brochures, and other study documents, and track revisions.
- Electronic Filing Systems: 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.
- Tracking Tools: Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams.
- Lab Sample Tracking: Perform lab sample tracking, utilizing the central lab database.
- Drug Supply Management: Perform drug supply tracking and management.
- Data Management: Review of data management aspects of clinical trials.
- Audit Support: Support clinical operations functions during audits (e.g., BIMO, FDA).
- Visit Reports: Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow-up items as requested.
- Study Plans: Participate in the review and finalization of study plans and circulate for approval.
- Day-to-Day Operations: 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.
- Quality Control: Perform QC of electronic Trial Master Files.
- Inspection Readiness: Fully understand the need for and importance of being inspection-ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps.
- Meeting Coordination: Accountable for ensuring that agendas for meetings are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings.
- Travel Coordination: Assist CRO with planning of Investigator Meetings and associated travel.
- Information Exchange: 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.
- Invoice and Budget Management: Support invoice and budget activities for clinical trials.
- Contract Review: Facilitate review of clinical trial agreements such as contracts and licenses.
- Risk Management: Identifies potential risks from study and site perspective and works with the CTM to assist in proactively resolving issues with CROs.
- EDC/IRT Testing: Participates in User Acceptance Testing (UAT) for Electronic Data Capture (EDC)/Integrated Randomization and Treatment (IRT) systems.
- Education: Bachelor's degree in scientific, biological, life sciences, or related field.
- Regulatory Knowledge: Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management.
- Organizational Skills: Strong organizational skills and enjoys working in a methodical way.
- Analytical Skills: Strong analytical and problem-solving skills.
- Interpersonal Skills: Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
- Attention to Detail: Attention to detail and quality.
- Communication Skills: Excellent written and oral communication skills.
- Technical Skills: Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).
- Adaptability: Flexible approach to change.
