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Clinical Data Manager

Katalyst HealthCares & Life Sciences
Redwood City, CA
Full-time

Responsibilities :

  • Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.
  • Assist in creating external data transfer agreements, ensuring alignment and specifications to support data integration, analysis, and reporting.
  • Provide support in setting up infrastructure for external data to flow into Clinical data pipelines.
  • Assist in validation of all Data generated in clinical trials into Clinical Data pipelines.
  • Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
  • Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT) group in formal inspections or audits.
  • Act as a representative for Takeda in interactions with key external partners as part of the CT Data Acquisition team.

Requirements :

  • Support timely submission and ongoing maintenance of study-related Data Acquisition documentation in TMF.
  • Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.
  • Escalate issues to CT leadership as appropriate
  • Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
  • Gain exposure to all phases of drug development.
  • Assist in handling Clinical data acquisition and management
  • May support study-level negotiation and agreement for data transfer or integration
  • Collaborate with all levels of employees with moderate supervision required.
  • Familiarity with FTP tools like Global cape, Clinical platforms like Veeva CDMS, Illuminate, and Veeva TMF will be beneficial.
  • 30+ days ago
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