Job is located in Irvine, CA.
Ascent Pharma is seeking a Clinical Data Manager in Irvine, CA!
***APPLY TODAY OR REFER A FRIEND! We offer a terrific referral bonus!
Madelene Marinas/ Sr. Clinical Recruiter
Please send your resume directly to: email@example.com
Clinical Data Manager
WHAT YOU WILL BE DOING:
The Clinical Data Manager will participate in the review of Clinical research documents (eg. Protocols, Case Report Forms);
The Clinical Data Manager will 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 Data Handling Plan;
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, 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. WHAT SKILLS ARE REQUIRED:
Ascent Pharma, a division of Ascent, specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry .
- The Clinical Data Manage r should have a Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
- The Clinical Data Manage r should have at least 2 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.
CareerBuilder - 14 months ago