Clinical Trial Manager, Clinical Operations

Spyre Therapeutics; United States; Remote; USD 135,000 - 155,000; Full time

Job summary

Spyre Therapeutics is seeking a Clinical Trial Manager to oversee clinical trials from start to finish. The role involves managing vendor selection, ensuring compliance with regulations, and collaborating with internal teams. The ideal candidate has extensive clinical research experience and strong leadership skills. This position offers competitive compensation and the opportunity to work in a dynamic environment focused on innovative therapies.

Benefits

Unlimited PTO

Competitive compensation

Professional development opportunities

Qualifications

• At least 6 years of clinical research experience, with 2+ years managing early-phase trials.
• Strong knowledge of clinical operations and study conduct.

Responsibilities

• Manage Clinical Trials from vendor selection through CSR completion.
• Ensure activities meet quality standards including ICH/GCP.
• Develop operational plans for efficient enrollment and monitoring.

Skills

Leadership

Communication

Clinical Operations

Regulatory Compliance

Education

B.A./B.S. in life sciences

Job description

Clinical Trial Manager, Clinical Operations

Join to apply for the Clinical Trial Manager, Clinical Operations role at Spyre Therapeutics

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 managing 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 and external CRO partners to drive successful trial execution, advancing the development of our antibody conjugate portfolio with a focus on efficacy, safety, and regulatory compliance.

Key Responsibilities

• Manage Clinical Trials from vendor selection through CSR completion.
• Ensure activities are completed on time, within budget, and meet quality standards including ICH/GCP.
• Create and implement study-specific monitoring tools and documents, including informed consent and EU CTR compliance.
• Identify, evaluate, select, and oversee clinical trial sites.
• Develop operational plans to ensure efficient enrollment and high-quality monitoring.
• Review and approve vendor and site invoices; track study budget.
• Maintain Trial Master File for inspection readiness.
• Support development of study documents like protocols, consent forms, and budgets.
• Create project plans, logs, templates, and reports.
• Review site documents such as informed consent forms and monitoring reports.
• Provide study updates, including risks and issues.
• Lead meetings with investigators, conferences, and study management teams.
• Oversee data reviews, cleaning activities, and trial activities like site initiation and close-out.
• Manage quality risk and study supplies.
• Coordinate study training for investigators and staff.
• Participate in audits and inspections.
• Perform other duties as assigned.

Ideal Candidate

• B.A./B.S. in life sciences or equivalent.
• At least 6 years of clinical research experience, with 2+ years managing early-phase trials; experience with global trials is a plus.
• Inflammation/Immunology experience preferred.
• Strong knowledge of clinical operations and study conduct.
• Experience with informed consent development and EU CTR.
• Ability to lead cross-functional teams in a matrix environment.
• Knowledge of FDA/ICH guidelines and industry standards, including GCP.
• Excellent communication and leadership skills.

What We Offer

• Fast-paced, dynamic environment with opportunities to shape company culture and contribute to meaningful medicines.
• Competitive compensation, including salary, bonus, equity, and benefits.
• Unlimited PTO and company-wide shutdowns.
• Professional development opportunities.
• Remote work with in-person meetings as needed.

The expected salary range is $135,000 to $155,000, with actual offers based on experience and location.

Spyre is an equal opportunity employer committed to diversity and inclusion. Be cautious of email scams; official communications are only from @spyre.com addresses. All job postings are on our website at spyre.com/careers/.