Clinical Data Manager/Senior

April 13

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Adverum Biotechnologies logo

Adverum Biotechnologies

We are on a global mission to establish gene therapy as a new standard of care for highly prevalent ocular diseases.

Gene Therapy • Biotechnology • Rare Diseases • Ophthalmology • Retina

51 - 200

💰 $217M Post-IPO Equity on 2020-08

Description

• Responsible for data management activities across studies • Compliance with regulatory guidelines and best practices • Oversight of CRO DM Vendor • Collaborate with cross-functional team • Quality assurance of clinical data • Lead data deliverables and database locks • Facilitate Data Review Meetings • Support TFL reviews and regulatory submissions • Maintain TMF and archive trial documentation

Requirements

• Bachelor's degree in life science, computer science, or related discipline • 5+ years (CDM) / 8+ years (Sr. CDM) experience in pharmaceutical or CRO environment • Proficiency in EDC Systems and data management processes • Good working knowledge of ICH, FDA, and GCP regulations • Experience with web-based Electronic Data Capture (EDC) systems • Knowledge of industry standards (CDISC, CDASH, SDTM) • Proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel • Excellent organizational and communication skills • Ability to work independently and in a team setting

Benefits

• Competitive salary • Health, dental, and vision insurance • Retirement savings plan • Paid time off • Professional development opportunities

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