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Full-Time

Senior Data Manager

Clinical Data

Confirmed live in the last 24 hours

4D Molecular Therapeutics

4D Molecular Therapeutics

51-200 employees

Develops gene therapy products for serious diseases

Biotechnology

Compensation Overview

$164k - $196kAnnually

Senior, Expert

Oakland, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Management
Requirements
  • Bachelor’s degree or higher in life-science-related fields
  • 6+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers
  • At least 3+ years in a lead study data manager role
  • Experience in retina diseases and/or gene therapies a plus
  • Hands-on operational experience as Data Management Lead in all phases of clinical trials
  • Experience in vendor management and performance assessments
  • In-depth knowledge and expertise with CDISC data standards and models
  • Proficient in using clinical data management systems like Medidata Rave
  • Knowledge of ICH GCP and other applicable regulatory rules and guidelines
  • Knowledge of the clinical development process
Responsibilities
  • Lead Data Management of a clinical study or a series of related studies with minimal guidance
  • Manage and monitor the progress of data management activities with CROs, vendors, and stats/programming groups on assigned studies
  • Review protocols for appropriate data capture, including electronic Case Report Form (eCRF) design
  • Lead the development of data edit check specifications and data listings
  • Coordinate Electronic Data Capture (EDC) system design and testing according to company standards
  • Develop or lead the development of the Data Management and Data Transfer Plan for assigned clinical studies
  • Attend study meetings and provide Data Management updates and metrics
  • Review and provide feedback on other study documents
  • Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members
  • Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database
  • Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities
  • Lead database upgrades/migrations, including performing User Acceptance Testing
  • Maintain data management files / eTMF
  • Perform and coordinate database interim snapshot, lock, and freeze activities
  • Other duties as assigned
4D Molecular Therapeutics

4D Molecular Therapeutics

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4D Molecular Therapeutics, a clinical stage biopharma company, excels in genetic medicine with a focus on curative therapies across various specialties such as ophthalmology, pulmonology, and cardiology. They leverage a unique vector discovery platform, Therapeutic Vector Evolution, which employs directed evolution to design uniquely effective vectors. This commitment to tailored therapeutic solutions and cutting-edge technology makes it an exceptional workplace for professionals passionate about pioneering in the field of genetic medicine and contributing to significant advancements in healthcare.

Company Stage

IPO

Total Funding

$595M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

15%

1 year growth

22%

2 year growth

46%