Responsibilities :
- Executes, manages and conducts studies associated with the company’s clinical development plans.
- Assists directly with project start-up, this will include the development of budgets, contracts, financials, disclosure statements and grant payments.
- Provides support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies.
- Assists in the oversight, processing and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF) and Monitoring Reports.
- Reviews both Investigator and Project files throughout a clinical trial and follows up with CSM on any discrepancy or missing documents.
Requirements :
- Bachelor’s degree in related field combined with a minimum of 4 years of related experience.
- Clinical operations experience in phase 2 to phase 3 clinical trials including global clinical trials.
- Working knowledge of ICH GCP regulations.
- Must have extensive experience working in a sponsor environment.
- Experience in Pulmonary hypertension research.
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