Clinical Data Manager

4 weeks ago


Woburn, Massachusetts, United States Innova Solutions Full time

Job Summary: We are seeking a highly experienced Clinical Data Manager to join our team at Innova Solutions. As a Clinical Data Manager, you will be responsible for ensuring compliance with regulatory standards and company SOPs in data management activities.

Key Responsibilities:

  • Assist in the preparation of data for regulatory submissions and audits.
  • Provide data-related support during clinical trial activities and interactions with regulatory agencies.
  • Maintain detailed documentation of data management activities and quality control measures.
  • Work closely with clinical research teams, biostatisticians, and other stakeholders to support submission preparations.

Requirements:

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Data Management, Biostatistics).
  • At least 7 years of experience in Data Management, particularly with submission preparation experience.
  • Proven experience in clinical data management, preferably in a pharmaceutical, biotechnology, or clinical research setting.
  • Knowledge of regulatory requirements and industry standards for clinical data management.
  • Strong attention to detail and organizational skills.

About Innova Solutions: Innova Solutions is a global technology and business transformation solutions provider. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.


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