Job Description

Responsibilities:

• Act as primary liaison between Company and CRO for Data Management.
• Provide support and oversight for the CRO Data Management team.
• Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs.
• Review clinical study protocols and provide comments if any.
• Provide leadership and support for cross-functional tasks, processes, and training.
• Provide oversight and manage relationships with external vendors.
• Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.
• Monitor data cleanup activities performed by CRO.

Requirements:

• Master's degree or higher in science or related discipline.
• Minimum of 5 years of CDM experience in pharmaceutical/biotech industry.
• Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
• Thorough and broad knowledge of data management processes, including EDC and interactive web response system (IWRS) experience.
• Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
• Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials.

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