Remote Clinical Data Manager — Temporary

Regeneron Pharmaceuticals, Inc.

United States

A distancia

USD 85.000 - 110.000

A tiempo parcial

Hace 2 días
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Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Temporary Clinical Data Manager to join our Clinical Data Management team, supporting our clinical studies in a remote work model.

You will ensure clinical data is accurate, compliant, and ready for analysis while collaborating with CROs and cross-functional study teams. The role emphasizes data validation, database build and documentation, with opportunities to lead the data management team and contribute to life-changing

Formación

  • Bachelor’s degree in mathematics, science, or a related field.
  • 3 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
  • Ability to coordinate and manage CRO data managers and project teams to ensure adherence to policies and procedures.
  • Strong understanding of data management processes, database validation, and regulatory compliance.
  • Excellent collaboration, organization, and communication skills.
  • Oncology and/or ophthalmology experience preferred.

Responsabilidades

  • Serve as the primary data management contact for assigned studies, representing the function on project teams and partnering with CROs.
  • Coordinate and lead clinical data management activities in line with company SOPs, policies, and regulatory requirements.
  • Monitor CRO data clean-up from study start-up through data archiving to protect data quality and integrity.
  • Coordinate medical coding, data validation checks, and database snapshots, and provide data for analysis.
  • Create and maintain study documentation, including the Data Management Manual, CRF completion guidelines, and validation specifications.
  • Design and modify CRFs, and initiate and approve the build, testing, and validation of clinical databases.
  • Prepare and distribute project status reports to project teams and management.
  • Lead the DM team in ensuring databases are validated and ready for transfer and analysis, while supporting standardization of outsourcing partner processes.

Conocimientos

Clinical data management
CRO coordination
Regulatory compliance
Data validation
Team leadership
Oncology experience

Educación

Bachelor’s degree in mathematics, science, or related field

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Temporary Clinical Data Manager to join our Clinical Data Management team, supporting our clinical studies in a remote work model.

You will ensure clinical data is accurate, compliant, and ready for analysis while collaborating with CROs and cross-functional study teams. The role emphasizes data validation, database build and documentation, with opportunities to lead the data management team and contribute to life-changing

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