Clinical Research Project Manager B

Job Description Summary

The Cardiovascular Clinical Research Unit (CCRU) supports a broad range of cardiovascular clinical trials across single-center and multicenter settings. The Project Manager B provides independent oversight of study operations, including project planning, team management, regulatory activities, and study execution. This role ensures studies are conducted according to protocol, regulatory requirements, and timelines, while supporting investigators and coordinating across internal and external collaborators.

Job Description

This position is contingent upon favorable funding.

Job Responsibilities

• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with Good Clinical Practice (GCP) and all applicable regulatory requirements.
• Lead study intake and drive start-up activities, including feasibility assessments, sponsor/CRO/vendor coordination, site activation, and completion of regulatory submissions and essential documents.
• Develop, create, and oversee regulatory submissions and study documentation, including protocols, informed consents, annual reports, safety reporting, and regulatory responses; assist with IND/IDE/CTA exemption determinations.
• Supervise, manage, and mentor study teams (typically 2-4 staff), including onboarding, training, workload management, and performance oversight; develop and drive study timelines, recruitment strategies, and operational plans.
• Contribute to budget development and PRA assessment in collaboration with investigators and finance teams; monitor study financial performance and ensure appropriate invoicing, billing, and reconciliation.
• Develop and maintain study tools and documentation, including source documents, case report forms (CRFs), manuals of procedures (MOPs), training materials, and standard operating procedures (SOPs).
• Lead internal and external study meetings (including sponsor, CRO, and multicenter collaborations); track action items and ensure timely resolution of issues.
• Oversee data quality, regulatory compliance, and study conduct, including audit/inspection readiness, monitoring follow-up, and quality control activities.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Perform additional duties as assigned.

Qualifications

Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.