Clinical Trial Operations Manager
hace 6 días
**Job Summary:**
We are seeking a skilled Clinical Trial Operations Manager to oversee the execution of studies and clinical trials according to the study protocol, ICH-GCP, applicable regulations, guidelines, and sponsor requirements.
**Key Responsibilities:
- Identify investigator sites and participate in the feasibility process for new studies
- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.E., ICH GCP
- Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
- Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
- Check the correct submission and completion of informed consent forms
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
- Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
**Requirements:**
- Enthusiastic, knowledgeable, and proactive individual
- University degree in a scientific/life science field
- At least 2 years of experience in managing and conducting clinical trials
- In-depth knowledge of ICH GCP principles
- Able to carry out independently all the activities related to the monitoring of clinical trials
- Good knowledge of Office Suite (Word, Excel, PowerPoint)
- Organizational and problem-solving skills
- Excellent written and verbal communication skills including a good command of the English language
- No restrictions to travel onsite
**Who We Are:**
OPIS is a full-service science-driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. Our company is headquartered in Italy and operates internationally.
**Estimated Salary Range:** €45,000 - €65,000 per annum, depending on location and experience
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