Description
The Job: The Clinical Project Manager will manage clinical development projects to ensure on time regulatory submission. Effective ongoing communication of the clinical development activities is critical. The Project Manager must have an excellent understanding of the drug/device development process in order to effectively lead the clinical project team.Essential Functions and Duties:
- Responsible and accountable for several clinical trials
- Facilitates investigational site budget negotiations
- Responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans
- Responsible for ensuring the trial is "audit ready" at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial)
- Assists with training and supervising junior level CRAs
- Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported
- Performs site monitoring, as needed
- Data Management: Vendor identification, SAP and DMP review and approval, edit specifications review and approval, ensuring query monitoring and resolution, review of data listings and clinical study report, as needed
Requirements:
- Bachelor's-level degree required in science/health related field (Masters degree is preferred)
- Minimum of 5 years clinical research and/or clinical project management experience
- Thorough understanding of GCPs and FDA and ICH guidelines
- Excellent written and oral communication skills
- Ability to manage multiple priorities and attention to detail are critical
To find out more about Real please visit www.realstaffing.com