Clinical Operations Manager
Technical Resources International

Bethesda, Maryland

Posted in Science and Research


This job has expired.

Job Info


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 [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. Prepares full (based on years of experience) or sections for monthly, quarterly, and annual 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 SaaS or project/contract-specific tool or system in support of one or more of the following: assistance to sites in patient recruitment; tracking of site monitoring activities and reporting; and/or regulatory document review/collection (including an understanding of Trial Master File requirements).
  • 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 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.


Job Requirements
Requirements:
  • Bachelor's Degree in life science or another health-related field (Master's Degree a plus)
  • 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.

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