Spyre Therapeutics

Clinical Operations

• 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 of study training to investigators, site staff and internal staff on study processes.
• Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
• Other duties as assigned.

Clinical Trial Manager, Clinical Operations