Heart Rhythm Clinical Research Solutions

The Senior Project Manager is responsible for the end-to-end planning and execution of cardiac-focused medical device clinical trials and registries. This includes serving as the primary strategic liaison for clients and leading cross-functional teams to ensure regulatory compliance and data integrity.

The Business Development Director leads go-to-market initiatives and drives commercial strategy across key growth areas. This role involves identifying new revenue opportunities and building senior-level relationships with key customers and partners.

This role involves identifying, documenting, and triaging system issues within the proprietary Electronic Data Capture (EDC) platform, while also translating Data Management needs into actionable technical requirements and feature requests. Additionally, the specialist will create and execute test scripts for system validation and maintain accurate system documentation and user guides.

The Sr. Clinical Data Manager will lead and oversee all data management activities for medical device clinical trials, ensuring compliance with FDA, MDR, ICH-GCP, and ISO 14155 regulations through DMP/CRF development and EDC system management. This includes overseeing data cleaning, query management, and ensuring adherence to CDISC standards for efficient regulatory submission.

The manager will be responsible for generating and advancing revenue opportunities for the CRO arm by building a high-quality pipeline, progressing deals through defined stages, and closing business to meet aggressive growth plans. This involves executing both new logo acquisition ('Hunting') and expansion within existing accounts ('Farming') to deliver future revenue targets.