Clinical Data Manager

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Job Title:
Clinical Data Manager – Mid-Level

Location:
United States or Canada (Remote/Hybrid)

Employment Type:
Full-Time

Position Overview

We are seeking a highly skilled and detail-oriented Clinical Data Manager with a minimum of 5 years of experience in clinical data management. The ideal candidate will have proven expertise in writing specifications, conducting user acceptance testing (UAT) for listing programs, and performing data review in accordance with a defined Data Review Plan (DRP). This role requires a strong understanding of clinical trial processes, regulatory standards, and technical systems used in data management.

Key Responsibilities

• Develop detailed specifications for clinical data listings and collaborate with programming teams
• Conduct User Acceptance Testing (UAT) to validate the accuracy and compliance of listings
• Perform comprehensive data review activities following the Data Review Plan
• Ensure data quality and integrity in alignment with clinical protocols and regulatory requirements
• Support EDC system setup, validation, and maintenance
• Collaborate effectively with cross-functional teams including Biostatistics, Clinical Operations, and Medical Writing
• Participate in audit preparedness and contribute to documentation for regulatory submissions

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
• Minimum 5 years of experience in Clinical Data Management within pharmaceutical, CRO, or biotech environments
• Strong knowledge of ICH-GCP guidelines and FDA 21 CFR Part 11 compliance
• Proficiency in EDC systems (e.g., Medidata Rave, Oracle InForm), CDMS platforms, and Microsoft Office
• Demonstrated ability to manage multiple priorities with excellent organizational and time management skills
• Strong analytical thinking, problem-solving, and project management capabilities
• Excellent written and verbal communication skills with the ability to collaborate across teams

• Mid-Senior level

• Full-time

• Other, Health Care Provider, and Analyst

• Pharmaceutical Manufacturing

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