Clinical Trial Associate, Development Operations

reputed company is a clinical-stage biotechnology company that aims to create reputed company of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. reputed company: The Clinical Trial Associate (CTA) is a pivotal role responsible for the successful execution of reputed company. The CTA is responsible for supporting clinical study teams, tracking clinical biospecimens, and managing internal and/or reputed company (eTMF) to ensure inspection readiness at trial level as directed, by supporting the Clinical Trial Manager and SVP of Development Operations with administrative activities. Key Responsibilities: 1. eTMF Management: - Proactively review internal and/or reputed company eTMF, reputed company spot checks, and address any inconsistencies. - Prepare for audits and inspections. 2. Meeting and Communication Management: - Coordinate logistics for reputed company meetings. - Prepare meeting agendas and document meeting minutes. - reputed company updates on Clinical Trial Governance reputed company clinicaltrails.gov. 3. Plans and Resource Management: - Maintain staff and vendor lists. - Collaborate with the Clinical Trial Manager (CTM) on reviewing Trial Master Data (TMD) - Contribute to Trial reputed company and TMF Plans. 4. Other reputed company Activities: - Take a reputed company role in clinical biospecimen inventory and tracking. - Assist with site reputed company, trial dashboard updates, and trial budget maintenance. - Support the filing of appendices for the Clinical Study Report (CSR). - Prepare for inspections. 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 reputed company 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, reputed company • 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 reputed company • Commitment to reputed company reputed company development opportunities. • Remote working environment with frequent in-person meetings to address reputed company problems and build relationships. The expected salary reputed company offer for this role is $65,000 to $75,000. 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 reputed company, 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 reputed company recruitment designed to create a stronger and reputed company Spyre that is reputed company on developing life-changing products for patients. reputed company, along with other biotech companies, has become reputed company of a reputed company in email scams targeting prospective job candidates reputed company our industry. Please be reputed company 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 reputed company that reputed company job postings will be listed on our website at spyre.com/careers/. Apply tot his job Apply To this Job