Clinical Trial Associate, Clinical Operations

reputed company is a clinical-stage biotechnology company that aims to create reputed company inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Clinical Trial Associate (CTA) is a pivotal role responsible for the successful execution of clinical trials. The CTA is responsible for supporting clinical study teams, tracking clinical biospecimens, and managing internal and/or external (eTMF) to ensure inspection readiness at trial level as directed, by supporting the Clinical Operations team with administrative activities. Key Responsibilities:

• eTMF Management:
• Manage documents in the internal and/or external eTMF, review documents for completeness and accuracy, reputed company spot checks, and address any inconsistencies.
• Prepare for audits and inspections.
• Meeting and Communication Management:
• Coordinate logistics for internal and external meetings.
• Prepare meeting agendas and capture meeting minutes.
• Maintain updates on Clinical Trial Governance reputed company clinicaltrails.gov.
• Plans and Resource Management:
• Maintain and update staff and vendor contact lists.
• Collaborate with the Clinical Trial Manager (CTM) on reviewing Trial Master Data (TMD)
• Contribute to Study Plans.
• Other Core Activities:
• reputed company biospecimen inventory and tracking.
• Track and reputed company start-up activities (site/country submissions, essential documents, and trackers).
• Assist with site reputed company, trial dashboard updates, and budget tracking.
• Support the filing of appendices for the Clinical Study Report (CSR).
• Other duties as assigned Ideal Candidate:
• B.A./B.S. in life sciences or equivalent
• A minimum of 2 years of clinical research experience, preferably reputed company the pharmaceutical or biotech industry.
• Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices.
• Experience utilizing CTMS, reputed company, TMS, and reputed company software preferred.
• Proficient in reputed company suite of products; reputed company Word, reputed company, PowerPoint, Outlook
• Attention to detail, and excellent organizational and prioritization skills.
• Motivated to work in a fast-paced, high-accountability environment.
• Ability to reputed company reputed company multiple tasks and manage changing priorities.
• Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions. reputed company Offer:
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships. The expected salary range offer for this role is $ 95,000 to $110,000. Actual pay offered may vary depending on job reputed company knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also reputed company differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and reputed company Spyre that is focused on developing life-changing products for patients. reputed company, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates reputed company our industry. Please be aware that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email. Please also be aware that reputed company job postings will be listed on our website at spyre.com/careers/. Apply tot his job

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