Clinical Data Manager

23 hours ago


South Plainfield, New Jersey, United States Lifelancer Full time
Clinical Data Manager Job Description

Lifelancer is seeking a highly skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for ensuring the accuracy, completeness, and integrity of clinical trial data.

Key Responsibilities:
  • Act as the primary liaison between Lifelancer and Contract Research Organizations (CROs) for data management.
  • Provide support and oversight for CRO Data Management teams.
  • Collaborate with cross-functional teams on study design, protocol development, CRF design, statistical planning, and CSRs.
  • Review clinical study protocols and provide comments as needed.
  • Provide leadership and support for cross-functional tasks, processes, and training.
  • Manage relationships with external vendors and ensure compliance with regulatory requirements.
Requirements:
  • Master's degree or higher in a science or related discipline.
  • Minimum of 5 years of CDM experience in the pharmaceutical/biotech industry.
  • Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
  • Thorough knowledge of data management processes, including EDC and IWRS experience.
  • Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. If you are a motivated and detail-oriented individual with a passion for data management, we encourage you to apply for this exciting opportunity.


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