[Remote] Director Clinical Research (Clinical Monitoring Team)

Note: The job is a remote job and is open to candidates in USA. Heart Rhythm Clinical Research Solutions is a full-service CRO that combines cardiovascular expertise with a network of physicians to deliver innovative solutions in clinical research. The Director Clinical Research will lead the Clinical Monitoring Team, overseeing clinical trial management from planning to execution, while fostering client relationships and driving process improvements.

Responsibilities

• Develop strong customer and client relationships ensuring appropriate expectations are met and exceeded
• Help develop talent, set goals, align on expectations and drive accountability with direct reports as well as identify future strategic direction across clinical operations portfolio
• Maintain up-to-date knowledge of regulatory requirements related to study management
• Track and follow-through on process improvement projects as well as studies we are supporting
• Determines study objective, strategy, scope and schedule to meet business needs
• Able to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget
• Able to see multiple viewpoints and build consensus to reach resolutions
• Supports the development of the Clinical Investigational Plan and supporting documents (ICF, Monitoring Plan, Data Management Plan, etc.) in consultation with the cross-functional project teams
• May provide clinical training of investigators, center staff, and internal team members
• May evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study execution
• May participate in the selection and management of CRO vendors and contractors
• May provide oversight/review of monitoring reports, CTMS/eTMF process implementation, and lead special projects for the portfolio
• Develops a high level of professional scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/outside experts or departments/institutes
• May develop and manage budgets for assigned clinical research projects
• Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership
• Follows and helps iterate Clinical SOPs, systems and processes ensuring quality study management
• Performs other duties as assigned

Skills

• Bachelor's degree in a life science or related field. However, a combination of experience and/or education will be taken into consideration
• Minimum of 8 years of experience within a Contract Research Organization (CRO), biotech, or pharmaceutical company with significant clinical research experience
• Minimum 2 years of people management experience
• Knowledge of GCP, FDA, and other regulatory requirements related to trial management
• Strong attention to detail and organizational skills
• Good communication, interpersonal skills, and talent management skills
• Healthy disdain for the status quo
• Ability to thrive in a fast-paced and dynamic early-stage company work environment

Company Overview