Responsibilities:

• Oversight of clinical operations activities, including clinical project management, clinical site management (essential regulatory document collection/review within a sponsor-specified data system and/or TMF, study start up, site monitoring), and/or clinical study management (study design, TMF documentation review/ collection/ management) with an understanding and working knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and scientific/ technical writing processes and requirements, to primarily support government contracts with the National Institutes of Health in multiple therapeutic areas, i.e., infectious disease (vaccines and treatments), oncology, and drug abuse.
• Responsible for project management oversight of one or more complex drug development programs while managing deliverables within budget and to well-defined timelines.
• Responsible for one or more department functional areas.
• Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
• 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 required by the client.
• Contributes to Corporate Initiatives, e.g., SOP development and proposals for government and commercial clients.
• Includes line management responsibility and staff hiring activities.
• Participate in proposal writing, budget development, and bid defense meetings, as needed.

Requirements:

• Bachelor's Degree in a life science or another health-related field (PhD, PharmD, MD, or master's degree a plus).
• 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/or product development life cycle.
• Able to mentor staff and achieve high quality performance through risk management/ mitigation and implementation of corrective/ preventive actions, as needed.
• Strong facilitation, presentation, problem-solving, and conflict resolution skills; including ability to keep up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools.
• Strong leadership skills including change management, people development, strategic thinking, and influencing.
• Advanced ability to manage team resources to ensure attainment of department objectives.
• Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project.
• Proposal writing and bid defense skills a plus.
• Background in Infectious Disease/HIV clinical trials and/or Oncology; or experience in the conduct of Phase 1 protocols or prior work on a government contract, is a plus.

Job Snapshot