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Clinical-Scientific Document Specilaist or Manager

Novartis Pharmaceuticals Corporation

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Location:
East Hanover, NJ
Posted Date:
8/1/2014
Position Type:
Full time
Job Code:
133413BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

We are sourcing for a future opening.

This position will be filled at a level commensurate with experience.

Local candidates strongly preferred
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Job Purpose:
Responsible for all aspects related to the review and approval of clinical trial protocols and related documents in OGD&GMA, with supervision as needed

Major Accountabilities:
Responsible for timely review of protocol documents in preparation for Oncology Protocol Review Committee (p)OPRC and follow-up

Keep meeting minutes of (p)OPRC and issue on PRC Document Tracker

With guidance as needed, verify the protocol, based on the Protocol Checklist, for past meeting Action Items and support the approval within the protocol timelines (after the (p)OPRC review of the synopsis)

After OPRC discussions, share “lessons learned” with OPM team members

Along with senior team members, participate in the support and development of training program for clinical teams for topics related to the (p)OPRC process

Collaborate with the OPM Coordinator/Admin to ensure the OPM SharePointe space is up-to-date

Support the organization of joint (p)OPRC meetings

Function as back-up for the meeting coordination for (p)OPRC

Additional OPM activities as needed
EEO Statement  The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements  Degree:
BS/BA in a life science is required; an Advanced degree in a life science/ healthcare is preferred.

Languages:
Fluent English (oral and written)

Experience:
3-5 years of operational and trial management experience in the planning, execution, reporting, and publishing of clinical studies.

Experience in preparing clinical trial protocols is strongly preferred

Sound knowledge and experience of the global clinical development processes

Working knowledge of clinical trial design, statistics, and regulatory processes is required

Relevant experience in the quality control of clinical trial documentation

Knowledge of SOPs related to the management of clinical trials and protocol development

Working knowledge of CREDI (a Novartis clinical documentation system) is preferred

Requirements

Degree:
BS/BA in a life science is required; an Advanced degree in a life science/ healthcare is preferred.

Languages:
Fluent English (oral and written)

Experience:
3-5 years of operational and trial management experience in the planning, execution, reporting, and publishing of clinical studies.

Experience in preparing clinical trial protocols is strongly preferred

Sound knowledge and experience of the global clinical development processes

Working knowledge of clinical trial design, statistics, and regulatory processes is required

Relevant experience in the quality control of clinical trial documentation

Knowledge of SOPs related to the management of clinical trials and protocol development

Working knowledge of CREDI (a Novartis clinical documentation system) is preferred

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