Senior Clinical Trial Associate, Inflammatory Bowel Disease Specialist

4 weeks ago


Waltham, Massachusetts, United States Lifelancer Full time
Unlock a Rewarding Career in Clinical Trials

In this pivotal role as Senior Clinical Trial Associate, you will play a crucial part in shaping the future of inflammatory bowel disease (IBD) treatments. Join our dynamic team at Spyre Therapeutics, a clinical-stage biotechnology company dedicated to creating innovative therapies for patients.

Competitive Salary Range: $65,000 - $75,000 per annum

About the Role

This senior position requires a motivated and detail-oriented individual with a strong background in clinical research. As a key member of our clinical trial team, you will be responsible for the successful execution of trials, ensuring timely delivery and high-quality results. Your expertise will be instrumental in driving our mission forward.

Main Responsibilities:

  • eTMF Management: Review and maintain electronic Trial Master Files (eTMFs), performing spot checks and addressing inconsistencies to ensure inspection readiness.
  • Meeting and Communication Management: Coordinate logistics for internal and external meetings, prepare agendas, and document meeting minutes.
  • Plans and Resource Management: Maintain staff and vendor lists, collaborate with the Clinical Trial Manager on reviewing Trial Master Data (TMD), and contribute to Trial Oversight and TMF Plans.
  • Clinical Biospecimen Inventory and Tracking: Lead efforts to manage and track clinical biospecimens, ensuring compliance with regulations and company policies.
  • Other Core Activities: Assist with site contracts, trial dashboard updates, and trial budget maintenance, supporting the filing of appendices for the Clinical Study Report (CSR).

Ideal Candidate:

  • B.A./B.S. in life sciences or equivalent.
  • A minimum of 2 years of clinical research experience, preferably within the pharmaceutical or biotech industry.
  • Working knowledge of FDA/ICH guidelines and industry standard practices, including Good Clinical Practices.
  • Experience utilizing CTMS, EDC, TMS, and related software preferred.
  • Proficient in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook.
  • Attention to detail, excellent organizational and prioritization skills.
  • Motivated to work in a fast-paced, high-accountability environment.
  • Ability to efficiently perform multiple tasks and manage changing priorities.
  • Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.

We Offer:

  • Market competitive compensation package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
  • Unlimited PTO.
  • Two one-week company-wide shutdowns each year.
  • Commitment to provide professional development opportunities.
  • Remote working environment with frequent in-person meetings to address complex problems and build relationships.

Lifelancer Platform Partnership: This job posting is brought to you through our partnership with Lifelancer, a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.



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