Spyre Therapeutics · 1 day ago

Associate Director, Data Management

US- Remote

Full-time

Remote

Director/Executive

$160K/yr - $190K/yr

10+ years exp

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Responsibilities

Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival

Conduct oversight of data management CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards

Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)

Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA)

Coordinate cross functional data review and provide proactively review of data trends and issue resolution

Qualification

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Data management experienceCRF designEDC experienceSDTMGCPICHRegulatory requirements knowledgeInterpersonal communication skills

Required

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

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.