Clinical Project Manager

Piper Health & Sciences is seeking a Clinical Project Manager (CPM) to join a well-established CRO in the greater Washington, DC area. This role focuses on project management for infectious disease and oncology trials. (Note: this is a hybrid role that requires weekly on-site travel.)

Responsibilities for the Clinical Project Manager include:

• Provide operational oversight of cross-functional project teams.

• Plan and manage day-to-day operational aspects of assigned programs/projects or tasks, including planning/timelines, budgeting, resourcing, and vendor management.

• Communicate with clients and program/project, distribute meeting agendas, and document meeting minutes.

• Ensure documentation of processes and workflows are being followed and occurring within projected timelines, determining course of action to prevent delays.

• Carry out various activities associated with the conduct and successful performance of clinical trials/studies with demonstrated expertise, including: 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).

• Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed.

• 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 in accordance with sponsor-specific requirements.

Qualifications for the Clinical Project Manager include:

• 2+ years of project management experience at a CRO is required. 5+ years of general CRO, sponsor, or a combination of either experience is required.

• Minimum of a Bachelor's degree in a scientific or related field is required. Master of Science in Regulatory Affairs, Pharmaceuticals, or similar is preferred.

• Working knowledge and application of FDA/EMA and other regulatory requirements, i.e., GCPs/ICH 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.

Compensation for the Clinical Project Manager includes:

• Salary Range: approximately $120,000 - $150,000 annually, commensurate with experience

• Benefits: Cigna Medical/Dental/Vision, ADP 401k, hybrid flexibility

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