Clinical Operations Manager

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. 

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.