Job Description

• Plans and manages day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, task assignment and completion tracking, budgeting, resourcing, and vendor management/interfacing.  Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [COR, or designee(s)], as needed.
• Provides operational expertise and/or oversight (based on years of experience) to cross-functional project teams, including task/functional managers who oversee the day-to-day operation for other functional areas.
• 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.
• Assists in generation of progress reports, and presents at internal and/or scientific meetings.
• Responsible for carrying out various activities associated with the conduct and successful performance of clinical trials/studies with demonstrated expertise in at least one project/contract-specific tool or system in support of one or more of the following: assistance to sites in study start-up, recruitment, and close-out; tracking of protocol and site activities and reporting; and/or regulatory document review/collection (including an understanding of Trial Master File/eTMF activities and requirements).
• Ensures project quality and compliance with FDA regulations and ICH guideline, and with NIH policies or other sponsors-specific requirements.
• Provides oversight and mentorship to staff in the delivery of quality work and performance, as per project deliverables, may include line management responsibility and staff hiring.
• Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed.
• Contributes to Corporate Initiatives, e.g., SOPs, Risk Reviews, and business proposals.
• Familiar with electronic systems utilized for various clinical activities (Monitoring, Study Start-Up, TMF) and the ability to manage the initiation and continued requirements of such systems. Includes ability to implement these systems for new clients or protocols as needed during a trial.

Job Requirements

• Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH guidelines and hands on regulatory, study start-up, TMF, or clinical operations experience.
• Demonstrated ability to take a leadership role, drive quality progress and deliver timely results.
• Strong presentation, problem-solving, and conflict resolution skills.
• Seasoned oral and written communication skills.
• Strong client management skills.
• Demonstrated project/task management skills, with team member oversight.
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.