MAJOR RESPONSIBILITIES AND DUTIES:
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 management team. Must be willing to travel up to 20%.
Responsibilities will include:
• Responsible and accountable for several clinical trials.
• Facilitate investigational site budget negotiations.
• Manages each project within agreed upon timelines.
• Provides regular updates to TI staff, 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). Ensures that any audit observations are addressed appropriately and in a timely manner.
• Responsible for ensuring that project team members are compliant with TI 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.
• Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
• Reviews and approves all monitoring reports and correspondence with sites from CRAs.
• Perform 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.
• Make effective oral and written presentations.
Bachelor’s-level degree required in science/health related field. A Master’s degree is a plus. The candidate should have a minimum of 5 years clinical research and/or clinical project management experience. A thorough understanding of GCPs and FDA and ICH guidelines is essential. Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail are critical.