Clinical Project Manager job in Bethesda at Technical Resources International
Technical Resources International

Bethesda, Maryland

Posted in Science and Research


This job has expired.

Job Info


Responsibilities:

  • Provide operational oversight of, and expertise to, cross-functional project teams, that will include task/functional managers who oversee the day-to-day operation for other functional areas.
  • Plan and manage day-to-day operational aspects of one or more assigned programs/projects,, including the following, as required: planning/timelines, budgeting, resourcing, and vendor management/interfacing. Identify and proactively work to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [Contracting Officer's Representative (COR), or designee(s)], as needed.
  • Interface with clients and program/project staff; ensure provision of meeting agendas and summary documentation, as well as detailed information required for internal and client meetings. Prepare and/or review sections for monthly, quarterly, and annual reports; may present at internal and/or scientific meetings.
  • 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.
  • Carry out numerous and varied activities associated with the conduct and successful performance of clinical trials/studies with demonstrated expertise and ability to navigate in at least one SaaS or project/contract-specific tool or system in support of the following: patient recruitment; data management, collection and processing of adverse events reports; tracking and reporting of site monitoring/management activities, and/or regulatory document collection (e.g., EDC, CTMS, or eTMF systems).
  • Represent eTMF and/or other clinical-trial related operations at study team meetings, participate in collaborative efforts and play an important cross-functional role, e.g., in eTMF document retrieval and management. Perform a risk-based review of activities being performed internally and by external vendors.
  • Perform duties within established SOPs and in accordance with Good Clinical Practice (GCP). Ensure project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsor-specific requirements.
  • Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities. Perform risk-based quality content reviews and monitor internal/external KPIs.
  • Provide oversight and mentorship to staff in the delivery of quality work and performance metrics, as per task order and/or project deliverables, expected to include line management responsibility and staff hiring.
  • 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.

Requirements
  • Bachelor's Degree in life science or another health-related field (Master's Degree a plus).
  • 5+ years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other clinical trials environment; e.g., regulatory or clinical operations (In-house CRA, study coordinator, regulatory documentation manager, or CRA/site monitor) experience.
  • Extensive knowledge and application of FDA/EMA and other regulatory requirements, i.e., GCPs/ICH (R2) guidelines to include domestic and global regulatory requirements.
  • 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.
  • Excellent leadership skills with demonstrated ability to take a leadership role and drive quality progress for a diverse team with specialized expertise.
  • Display excellent organizational skills and exhibit professionalism and integrity.
  • Demonstrated project and client management skills.
  • Strong presentation, problem-solving, and conflict resolution skills.
  • Seasoned oral and written communication skills.
  • Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project.
  • Background in Infectious Disease/HIV clinical trials and/or Oncology preferred; prior work on a government contract, is a plus.

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This job has expired.

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