Title: Quality Control (QC) Consultant

Location: Edison, NJ

Length: 1 Year+

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

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*||*

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