Clinical Project Manager:

  • Provide operational oversight of and expertise to cross-functional project teams, including task/functional managers who oversee the day-to-day operation of other functional areas.

  • Interacted with clients and program/project staff; ensured the provision of meeting agendas, summary documentation, and detailed information required for internal and client meetings.

  • Prepare and review complete sections for monthly, quarterly, and annual reports; present at internal and scientific meetings.

  • Ensure that documentation of processes and workflows is followed and occurring within projected timelines, and determine a course of action to prevent and remediate delays. Identify gaps and propose solutions to improve the efficiency and quality of deliverables. Maintain high accuracy and attention to detail in a fast-paced environment with shifting priorities.

  • Carry out numerous and varied activities associated with the conduct and successful performance of clinical trials/studies with demonstrated expertise and ability to navigate in at least one project/contract-specific tool or system in support of the following: patient recruitment; data management, collection and processing of adverse events reports; tracking and reporting of site monitoring/management activities, or regulatory document collection (e.g., EDC, CTMS, or eTMF systems).

  • Represent clinical-trial-related operations at study team meetings, participate in collaborative efforts, and play an essential cross-functional role.

  • Perform duties within established SOPs and following Good Clinical Practice (GCP). Ensure project quality and compliance with FDA regulations, the ICH (R2) guideline, and NIH policies or other sponsor-specific requirements.

  • Support and comply with the company's Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs as the client requires.

  • Job Requirements

  • Working knowledge and application of FDA/EMA and other regulatory requirements, i.e., GCPs/ICH (R2) guidelines, to include domestic and global regulatory requirements.

  • Broad multidisciplinary understanding of the pharmaceutical clinical research and development processes with hands-on regulatory, clinical operations, or clinical trial monitoring/management experience, e.g., clinical study design, conduct, management, reporting, and product development life cycle.

  • You have demonstrated the ability to take a leadership role and drive quality progress.

  • Expertise in Microsoft Word, PowerPoint, and Excel and experience with Microsoft Project are required.

  • A background in infectious disease/HIV clinical trials and oncology is preferred; prior work on a government contract is a plus.