Job Description

We are currently seeking an experienced Clinical Data Manager. In this position, you will lead the cross-functional teams to execute clinical research trials that deem whether new drugs or medical devices/products, are safe and effective.  

This position is eligible to be performed as a remote position.

• Act as primary point of contact between organization and CRO for Data Management.
• Provide support and oversight for the CRO Data Management team on multiple trials.
• Collaborate with the team on Clinical study design, protocol development, design, and statistical planning/outcomes.
• Review clinical trial/study protocols and provide commentary if necessary.
• Provide leadership and support for cross-functional tasks, processes, and training.
• Provide oversight and manage relationships with 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 the data cleanup activities performed by CRO.

Requirements:

• Bachelor’s degree or higher in science, math or related discipline.
• 3-5 years of CDM experience in pharmaceutical/biotech industry.
• Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
• Extensive knowledge of data management processes, including EDC and interactive web response system (IWRS) experience.
• 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
• Experience with MediData Rave and decentralized clinical trials highly desired but not necessary.

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