Clinical Project Manager

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 or tasks, 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 Officers 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 full or 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. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.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 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 clinical-trial related operations at study team meetings, participate in collaborative efforts and play an important cross-functional role.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.Provide oversight and mentorship to staff in the delivery of quality work and performance metrics, as per task order and/or project deliverables.Expect to include line management responsibility and staff hiring activities.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. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client.Contributes to Corporate Initiatives, e.g., SOP development and proposals for government and commercial clients.

Requirements

Working 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.Demonstrated ability to take a leadership role and drive quality progress.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.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.