Heart Rhythm Clinical Research Solutions · 1 day ago
Sr. Clinical Research Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expHeart Rhythm Clinical Research Solutions is a full-service CRO specializing in cardiovascular research. The Sr. Clinical Research Manager will lead the clinical data management strategy across multiple studies, ensuring high-quality and compliant data for regulatory submissions while providing leadership to the team.
Health CareMedicalMedical Device
Responsibilities
Drive the clinical data management vision, ensuring alignment with organizational goals, business needs, and regulatory/quality compliance
Assist in the development of Data Management Plans (DMPs), standards, templates, SOPs, and best practices
Lead continuous improvement initiatives to optimize workflows and enhance data quality and operations
Stay current on industry trends, regulatory updates, and emerging data technologies
Manage client and customer relationships to meet and exceed their expectations
Manage and mentor Clinical Data Managers and Clinical Data Specialists
Provide coaching, resource allocation, and performance development
Foster a collaborative, quality-driven team culture
Support team members in troubleshooting data workflows and quality processes
Oversee all CDM activities from study start-up through database lock
Lead DC system requirements, UAT, and maintenance
Ensure compliance with FDA 21 CFR Part 11, ISO 14155, ICH-GCP, and CDISC standards
Oversee data cleaning, discrepancy management, and reconciliation across data sources
Serve as primary CDM contact for clinical, regulatory, quality, statistics, and software/EDC partners
Ensure seamless communication and timely issue resolution
Support the Data management, clinical operations, and quality org design and strategic planning as a member of the Clinical leadership team
Support regulatory submissions through high-quality data documentation and audit readiness
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Clinical Research, Data Science, Health Informatics, or related field
8+ years of clinical operations or data management experience
2+ years of people management experience
Experience with EDC systems (RAVE, Veeva, InForm, Medrio, etc.)
Strong ability to manage multiple studies and cross-functional priorities
Strong leadership, communication, and mentoring abilities
Excellent analytical and problem‑solving skills
Ability to set strategic direction while managing operational details
Proficiency in data standards, EDC tools, and data review processes
Healthy disdain for the status quo
Preferred
CCDM certification preferred
Company
Heart Rhythm Clinical Research Solutions
Improving patients' lives by facilitating high quality clinical research through a collaborative network of physicians.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jose Osorio
Founder and President
Company data provided by crunchbase