Title: Quality Control (QC) Consultant

Location: Edison, NJ

Length: 1 Year+





*Need consultants who have worked for Pharma and specifically in Clinical
Trials*



Responsibilities and requirements for  QC Consultant



 Candidates  should have worked with direct GCP Document QC (Protocols,
Investigator Brochures, Clinical Study Reports)  and/or QA experience



1.  Ability to conduct an independent QC review on a variety of GCP related
study documents (eg, CSRs, protocols, and IB updates) according to Daiichi
Sankyo processes and Health Authority requirements/conventions, and
document the QC results

2.  Ability to provide input into QC plans and processes relating to Trial
Master File management;

3.  Ability to adapt easily to new circumstances and be flexible in a work
environment that makes frequent changes in its demands;

4.  Project management skills and the ability to work as part of a team;

5.  Ability to influence and maintain open and frequent communications with
external and internal (DS) stakeholders;

6.  Solid GCP knowledge and understanding of clinical trials

7.  Strong working knowledge of Microsoft Office Suite (PowerPoint, Excel);

8.  Light administrative tasks including meeting planning & scheduling







Thanks & Regards,



Ramesh Kumar

*Global **Associates Inc/ **VCarve Inc*

*||* 7106 Corporate Way* ||* Dayton, OH 45459 *||*

*||*Phone:  937-877-5870 * ||* Fax: 937-312-1205 *||*

ram...@gassociates.com* or*  ram...@vcarve.com *||* www.gassociates.com*||*
<http://www.gassociates.com||/>

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