Clinical Data Manager-Remote with some Travel

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Job Title: Clinical Data Manager

Location: Remote with some Travel

Duration : 12 months

Experience : 5+ years experience in Pharma/CRO companies as a Clinical Data Manager

Company Description

CRO company in the Boston area. The manager wants to have meeting sometimes in the office. Local candidates to the Boston area are best. Prior CRO company experience is best.

Role Description

• Lead day to day data management operations across multiple clinical trials, serving as the main client-facing contact
• Develop and manage Data Management Plans (DMPs) , timelines, resource allocation, and vendor coordination
• Ensure database design, CRF/eCRF development, and edit check programming meet CDISC or applicable standards
• Conduct and oversee User Acceptance Testing (UAT), discrepancy resolution , data cleaning, and review up to hard lock preparation
• Manage Serious Adverse Event (SAE) reconciliation , medical coding oversight, and database freeze/lock activities
• Support internal/external audits and regulatory inspections , responding to findings as needed
• Mentor and train junior data personnel; conduct peer reviews and quality checks Indeed+1
• Produce standardized reports and maintain study documentation (e.g., data binders, eTMF/TMF) MIT .

Qualifications

• Experience with clinical trial data management and knowledge of clinical data management systems (CDMS)
• Skills in data quality assurance, data cleaning, and data validation
• Familiarity with regulatory requirements and Good Clinical Practice (GCP)
• Proficiency in database design, CRF design, and database management
• Excellent analytical, organizational, and project management skills
• Strong communication and teamwork abilities
• Bachelor's degree in a scientific or technical discipline, or relevant experience

Aditya Kumar
Sr. Technical Recruiter

Email:

[email protected]

Telephone:
+1 732-795-9133