Job Description

Hello,

I hope you are doing well!

Kindly acknowledge me, are you Comfortable with this Position then please share me your updated resume.

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:

Aditya@stellentit.com

Address:
505 Knolle Court
Saint Augustine, FL 32092

Telephone:
+1 732-795-9133

Job Tags

Work at office, Local area, Remote work,

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