QA Project Manager - Clinical Research
Technical Resources International

Job Info

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Responsibilities:

• Plans and manages day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting, resourcing, and vendor management/interfacing. Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [Contracting Officer's Representative (COR), or designee(s)], as needed.
• Provides operational expertise to cross-functional project teams, including task/functional managers who oversee the day-to-day operation for other functional areas including oversight of various contracts consultants.
• Interfaces with client and program/project staff; ensures provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings. Prepares sections for monthly, quarterly, and annual reports; and, presents at internal and/or scientific meetings.
• Ensures project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsors-specific requirements.
• Provided oversight and mentorship to staff in the delivery of quality work and performance, as per task order and/or project deliverables, may include line management responsibility and consultant Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed.
• Contributes to Corporate Initiatives, e.g., SOP development and proposals for government and commercial clients.

Job Requirements
Requirements:

• Bachelor's Degree in life science or another health-related field (Master's Degree or PMP certification a plus)
• 5 to 7 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other clinical trials environment; e.g., hands on regulatory, clinical operations, project management , or quality management.
• Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH (R2) guidelines and hands on regulatory, clinical operations, or clinical trial monitoring experience.
• Demonstrated ability to take a leadership role and drive quality progress.
• Strong presentation, problem-solving, and conflict resolution skills.
• Seasoned oral and written communication skills.
• Demonstrated project/task management skills, with team member oversight.

This job has expired.