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Title : SA- Clinical Trial Operations Manager III -261
State : New Jersey   Date : Jan 10, 2019
Experience Level :  
Position Type : Clinical Trial Operations Manager III      
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: Bridgewater, NJ


Job Title: Clinical Trial Operations Manager III


Duration:  5+ months (extendable) contract on W2


Duties:



The Clinical Trial Operations Manager (CTOM) is responsible for part of the operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards. The CTOM supports the Senior Lead CTOM and/or Lead CTOM in the scientific conduct of the study and acts with a critical thinking and problem solving mindset. This role will be involved in the scientific conduct of the study and act under the guidance of the Senior Lead CTOM and/or Lead CTOM to guarantee release of homogeneous high quality data in close collaboration with others Clinical Science Operations (CSO) department representatives (e.g. Medical Operations). This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of client products. 



Skills:


Ability to manage and lead international meetings (e.g. Study Teams) Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team) Good Project coordination skills Good organizational skills including attention to details Ability to develop and maintain an optimized study planning with other functions (including identification of critical path) Ability to handle multiple tasks, prioritize his/ her activities Ability to coordinate multiple interfaces, both internally and externally Ability to anticipate, timely escalate issues and to define appropriate action plans Ability to work autonomously to efficiently and effectively provide status reports Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan Good written and verbal communication skills Good negotiation skills Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication) Alert on purpose, communicate on issues with proposed action plans Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first Experience in the management of vendors for outsourced activities is preferred Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers) Ability to learn from experience and develop a change mindset May assist trainees/Clinical Project Assistant/Trial Management Assistant and/or new comers in their self-development (project-related activities) Knowledge of International Standards (e.g. GCP, CDISC, ….), company tools, processes and SOPs Good working knowledge of Microsoft Office


Education:


Bachelor's degree plus At least 2 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 1 year of clinical research experience). Preferred: Advanced Degree in scientific discipline preferred, equivalent RN 3 years of experience in pharmaceutical industry, 2+ years clinical research experience and 1+ years of prior management and/or supervisory experience in coordinating vendors, budget management or country management



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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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