Description
Location: NJDuration: 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,