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Title : AXG- Principal Clinical Data Manager IV -638
State : Massachusetts   Date : Aug 6, 2020
Experience Level :  
Position Type : Principal Clinical Data Manager IV      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Boston, MA

Job Title: Principal Clinical Data Manager IV

Duration: 12+ months (extendable) contract on W2


Duties: 

Serve as lead CDM on 2 registry studies 
Attend internal and external study team meetings 
Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.  
Responsible for the managing the EDC database migration activities including obtaining update requirements from the study team, technical implementation approach from EDC builders, site impact assessment, etc.  Update EDC design documents as appropriate, support development, plan/oversee UAT execution, and update all related documentation (e.g., CRF completion guidelines, site training, Data Management Plan). 
Provide ongoing operational support for Medidata RAVE activities during registry trial conduct 
Provide ad-hoc report development, and support database lock and archiving activities.  
Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors. 
Support inspection preparation activities for registry studies including availability of project files, adherence to naming conventions, filing into the Trial Master File in a timely manner. 
Independently monitor own activities and project status for successful project deliverables according to timelines.

Skills: 

Experience in CDM for 7+years. 
Thorough knowledge of CDM SOPs and regulatory requirements 
Experience in vendor management of outsourced studies 
Experience in reviewing and validating clinical data; understanding/following clinical trial protocols and data collection documents. 
Medidata Rave experience required 
Effective written and verbal communication skills 
Demonstrate initiative, sound judgment and flexibility; effective time management and organizational skills

Education: Requires a Bachelor’s degree in a scientific discipline or equivalent. 



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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