Clinical Trial Manager

Job type:
on-site
Start:
07/2014
Duration:
n.a
From:
Real Staffing
Place:
New Jersey
Date:
07/12/2014
Country:
flag_no USA
project ID:
740667

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This project is archived and not active any more.
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Location: NJ
Duration: 6 month +
Rate: $65-70/hour

Requirements:
-BS degree
-Minimum of 3-5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
-Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections.
-Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics
-Knowledge of drug development and FDA GCP/ICH regulatory guidelines
Responsibilties:
-Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
-Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements

Yours sincerely,