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 $, - $, annually, commensurate with experience
• Benefits : Cigna Medical / Dental / Vision, ADP k, hybrid flexibility

Clinical project manager, clinical trial, clinical pm, cro, clinical research organization, infectious disease, oncology, cancer, research trial, clinical study, sponsor-initiated, investigator-initiated, regulatory compliance, ich, gcp, good clinical practices

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