Associate Director, Data Management

2 days ago

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Description

• Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease products. • Seeking analytical individual to serve as lead clinical data manager for clinical studies. • Responsible for providing input to protocols, designing and reviewing case report forms, and performing data management activities.

Requirements

• Bachelor’s degree is required • 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry • Hand-on knowledge and experience in data management activities, CRF and EDC design, review, and validation from various vendors • Knowledge of SDTM and experience in transforming raw data into these standards • Knowledge of GCP, ICH, and regulatory requirements • Successful track record of working independently in a matrixed organization and providing solutions to emerging problems • Excellent interpersonal communication skills, along with organizational skills

Benefits

• 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 base 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 complex problems and build relationships.

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