Clinical Trial Manager, Clinical Operations

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

The Clinical Trial Manager (CTM) is a pivotal role responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. The CTM will organize and supervise clinical trials, ensuring they meet all company and regulatory requirements. The CTM will collaborate closely with internal R&D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success.

Key Responsibilities:

• Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. 
• Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements.
• Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
• Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
• Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
• Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
• Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
• Provide study updates and reports, inclusive of study risks and issues.
• Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings.
• Responsible for ongoing study data reviews and data cleaning activities.
• Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
• Manage trial-level quality risk management.
• Oversee study supplies management.
• Support the development and complete the delivery …