Senior Manager, Data Management

2 months ago


Remote, Oregon, United States Apellis Pharmaceuticals Full time

Job Title: Senior Manager, Data Management at Apellis Pharmaceuticals, Inc.

The Senior Manager, Data Management takes the lead role in managing data for various clinical studies and/or a clinical development program. They provide direction and support throughout all stages of clinical studies, ensuring compliance with regulations and quality standards. Additionally, they oversee data management activities outsourced to CROs and contribute to operational improvements in data management.

Key Responsibilities:

  • Ensure CROs adhere to project timelines and agreements.
  • Develop metrics for effective oversight of CRO partners.
  • Collaborate with study teams and vendors to meet project goals.
  • Manage external data vendors and data cleaning processes.
  • Conduct data reviews and contribute to process improvements.
  • Participate in vendor qualifications and audits.
  • Lead study inspection readiness activities.
  • Train and mentor team members on data management processes.
  • Contribute to major projects and initiatives as needed.

Requirements:

  • Bachelor's degree in a science-related field.
  • Minimum 8 years of experience in clinical data management.

Skills & Abilities:

  • Extensive knowledge of clinical data management and outsourcing models.
  • Experience in managing CRO data managers and EDC systems.
  • Strong project management and communication skills.
  • Ability to work on multiple projects simultaneously and drive efficiency.
  • Experience with data visualization and analytics tools.
  • Understanding of regulatory requirements in clinical trials.

Work Environment & Travel:

  • Largely sedentary role with some filing requirements.
  • Expected travel up to 20%.

Company Overview:

Apellis Pharmaceuticals, Inc. is dedicated to developing innovative therapies for challenging diseases, including blindness and other serious conditions. With a focus on complement medicine, the company has made significant advancements in the field.

EEO Statement:

Apellis provides equal opportunities and adheres to fair employment practices laws to create a diverse and inclusive workplace. Discrimination of any form is not tolerated.

Disclaimer:

This job description may not encompass all duties and responsibilities, as tasks may evolve over time.



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