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Spyre Therapeutics · 2 hours ago

Senior Manager, Data Management

United States

Full-time

Remote

Senior Level, Lead/Staff

$170K/yr - $186K/yr

10+ years exp

Spyre Therapeutics is a clinical-stage biotechnology company focused on pioneering long-acting antibodies for inflammatory bowel disease and rheumatic diseases. They are seeking a Senior Manager, Data Management to lead clinical data management activities, ensuring data quality and compliance throughout the study lifecycle.

BiotechnologyTherapeutics

Responsibilities

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

Conduct oversight of and provide guidance to data management CROs to ensure that 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 proactive review of data trends and issue resolution

Other duties as assigned

Qualification

Data management experienceEDC systems knowledgeClinical systems implementationGCP knowledgeInterpersonal communicationOrganizational skills

Required

Bachelor's degree is required

10+ years of data management experience in the pharmaceutical, biotech, or CRO industry, with 5-8 years as a Lead Data Manager

Hands-on knowledge and experience in data management activities, such as CRF and EDC design, review, and validation of data from various vendors

Knowledge of real-time data flow across clinical systems

Strong knowledge of EDC systems (Medidata Rave, Veeva, or equivalent)

Knowledge of GCP, ICH, and regulatory requirements

Successful track record of working independently in a matrixed organization or in a start-up environment and providing effective 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.