Great Opportunity with a Leading CRO for a Clinical Data Manager! Option for 2 days work from home.
Title: Clinical Data Manager
Duties & Responsibilities:
Key responsibilities and skills may include, but are not limited to:
Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms).
Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and
ensures DMP is followed according to study design and requirements.
Create and maintain Data Validation Plan.
Create Data Entry Guidelines.
Create eCRF Completion Guidelines.
Create Data Transfer Specification.
Develop and review Case Report Form (CRF), electronic and/or paper.
Develop database (DB) clinical trial data specifications, including CRF annotation, edit
rules/checks, and query logic and data validations.
Perform external data reconciliation in collaboration with programmers.
Develop test scripts and execution logs for User Acceptance Testing (UAT).
Perform training on study trials and create user guides.
Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim
review, and or final database lock.
Coordinate the archiving of study databases and related documents.
Perform SAE reconciliation.
Perform other activities as required.
Provide mentorship to junior members.
Working with project manager and cross functional team members to maintain project timeline
and overall quality of deliveries.
Essential Skills Required & Education:
Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or
- At least 3 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications.