Clinical Research Project Manager Needed – Remote Work
Clinical Research Project Manager needed by our client to manage clinical development projects to ensure on time regulatory submission.
- Bachelor’s-level degree required in science/health related field. A Master’s degree is a plus.
- Five years clinical research and/or clinical project management experience.
- A thorough understanding of GCPs and FDA and ICH guidelines is essential.
- Must be willing to travel up to 20%.
Clinical Research Project Manager Job Description
The Clinical Research 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 management team.
Responsibilities will include:
- Responsible and accountable for several clinical trials.
- Facilitate investigational site budget negotiations.
- Manage each project within agreed upon timelines.
- Provide regular updates to sponsor, vendors and contract staff concerning status and progress of the trial.
- Facilitate protocol and related document development.
- 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).
- Ensure that any audit observations are addressed appropriately and in a timely manner.
- Responsible for ensuring that project team members are compliant with SOPs and internal guidelines.
- Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- Assist with training and supervising junior level CRAs.
- Responsible for developing presentations, handouts and coordination of investigator meetings.
- Perform oversight of the drug supply management
- Oversee trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
- Review and approves all monitoring reports and correspondence with sites from CRAs.
- Perform site monitoring, as needed.
- Perform 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.
- Make effective oral and written presentations.
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