Laboratory Data Management Manager

5 days ago

Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time
Job Title: Manager, Laboratory Data Management

About the Role:

The Manager, Laboratory Data Management, is a critical member of our team, responsible for delivering high-quality clinical lab data management services for assigned programs. This role collaborates with program teams, CROs, and vendors to ensure timely and accurate coding deliverables that support drug development processes and global submissions.

Key Responsibilities:

  • Lead the delivery of lab data management services for assigned programs, ensuring quality and timeliness of deliverables.
  • Collaborate with program teams, CROs, and vendors to drive lab data planning, collection, and maintenance activities.
  • Partner with Study Data Manager to identify and resolve laboratory data-specific issues and risks.
  • Manage Daiichi Sankyo standard local lab information Global Lab Analyte Mapping (GLAM) file and standard LNR Worksheet template.
  • Provide input on best practices and new processes related to laboratory data collection and management.
  • Instruct Lab Vendors and/or CROs on Daiichi Sankyo lab data standards and related processes.
  • Reinforce adherence to Daiichi Sankyo lab data standards across programs.
  • Monitor quality of deliverables and escalate performance or quality issues.
  • Participate in audits and inspections to provide study and/or program-level information on clinical lab data processing.

Requirements:

  • Bachelor's Degree or higher in life sciences or related field required.
  • 5+ years of laboratory background, with strong knowledge of LIMS, specimen management, and biomarkers tested in the oncology setting.
  • Clinical data management experience in a medical device, pharmaceutical company, or similar environment.
  • Working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus.

About Daiichi Sankyo, Inc.:

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. With over 125 years of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.

Why Join Us:

At Daiichi Sankyo, we offer a dynamic and collaborative work environment that fosters innovation, creativity, and growth. Our team is passionate about making a difference in the lives of patients and communities worldwide. If you share our commitment to excellence and innovation, we encourage you to apply for this exciting opportunity.

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