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Senior Manager, Data Management

3 months ago

Little Ferry, New Jersey, United States Apellis Pharmaceuticals Full time
Senior Manager, Data Management Position at Apellis Pharmaceuticals, Inc.

The Senior Manager, Data Management leads data management activities for clinical studies and development programs, overseeing data management tasks outsourced to CROs. They contribute to operational improvements by establishing standards, processes, and training.

Key Responsibilities Include:
  • Oversight of Clinical Data Management activities and adherence to service agreements
  • Developing Data Management metrics and key performance indicators
  • Ensuring project timelines and data quality
  • Collaborating with study teams and vendors for project deliverables
  • Managing external data vendors and data review processes
  • Reviewing and reporting on data performance
  • Contributing to process improvement efforts
  • Leading study inspection readiness activities
  • Mentoring staff and team members
Requirements:
  • Bachelor's degree in a science-related discipline
  • 8+ years of clinical data management experience
Skills & Abilities:
  • Extensive knowledge of data management outsourcing models
  • Experience in managing CRO data managers
  • Advanced knowledge of data management processes
  • Regulatory knowledge (ICH, GCP, HIPAA)
  • Project management and problem-solving skills

Physical Demands: Sedentary role with occasional filing requirements.

Travel Requirements: Up to 20% travel expected.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to developing therapies for challenging diseases.

For more information, visit Apellis Pharmaceuticals

EEO Statement:

Apellis is an equal opportunity employer and strictly prohibits discrimination.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, qualified applicants with arrest and conviction records will be considered.

Important Note: This job description may change over time without notice.