Senior Clinical Data Manager

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, as a Senior Clinical Data Manager and contribute to the development of targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. This U.S.-based remote role, with occasional visits to the San Francisco office, involves leading clinical data management activities for one or more clinical studies. You will oversee data management documentation creation, review clinical data and metrics, coordinate cross-functional reviews, and produce regular data listings. The ideal candidate possesses a Bachelor’s degree in a relevant scientific discipline, 3-5 years of data management experience in biotech/pharma/CRO, and knowledge of CDISC, SDTM, ICH GCP, and EDC systems. QED offers a competitive salary, comprehensive benefits, and opportunities for professional development.

Requirements

• Bachelor’s degree (or equivalent) in relevant scientific discipline preferred
• Minimum of 3-5 years of data management experience in the biotech, pharmaceutical and/or CRO setting; as well as experience with global studies
• Skills present in core data management activities (e.g., data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting)
• Knowledge of CDISC and SDTM standard terminology
• Knowledge of ICH GCP and Good Clinical Data Management guidelines
• Experience working with an Electronic Data Capture system (EDC) (e.g. Medidata Rave) and with other databases (e.g. Central Imaging, IVRS/IWRS)
• Proficient with MS Word, Excel and PowerPoint
• Strong interpersonal, communication (written and verbal), and organizational skills
• Demonstrated ability to work independently, as well as part of a multi-functional study team

Responsibilities

• Leads clinical data management activities for one or more clinical studies
• Oversees the creation and approval of Data Management study documentation by CROs and other vendors, to include CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans
• Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serves as a knowledgeable point person on study teams for data management activities
• Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites, and potential risks to timelines
• Reviews the deliverables of data management vendors to ensure accuracy and consistency with expected practices
• Coordinate cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings, and communication of post-review status
• Produces regular data listings for the clinical team and other functional areas
• Meets study timelines with a high degree of quality

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
• $150,000 — $185,000 USD