[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.ResponsibilitiesDevelop strong customer and client relationships ensuring appropriate expectations are met and exceededHelp develop talent, set goals, align on expectations and drive accountability with direct reports as well as identify future strategic direction across clinical operations portfolioMaintain up-to-date knowledge of regulatory requirements related to study managementTrack and follow-through on process improvement projects as well as studies we are supportingDetermines study objective, strategy, scope and schedule to meet business needsAble to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budgetAble to see multiple viewpoints and build consensus to reach resolutionsSupports the development of the Clinical Investigational Plan and supporting documents (ICF, Monitoring Plan, Data Management Plan, etc.) in consultation with the cross-functional project teamsMay provide clinical training of investigators, center staff, and internal team membersMay evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study executionMay participate in the selection and management of CRO vendors and contractorsMay provide oversight/review of monitoring reports, CTMS/eTMF process implementation, and lead special projects for the portfolioDevelops 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/institutesMay develop and manage budgets for assigned clinical research projectsPrepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadershipFollows and helps iterate Clinical SOPs, systems and processes ensuring quality study managementPerforms other duties as assignedSkillsBachelor's degree in a life science or related field. However, a combination of experience and/or education will be taken into considerationMinimum of 8 years of experience within a Contract Research Organization (CRO), biotech, or pharmaceutical company with significant clinical research experienceMinimum 2 years of people management experienceKnowledge of GCP, FDA, and other regulatory requirements related to trial managementStrong attention to detail and organizational skillsGood communication, interpersonal skills, and talent management skillsHealthy disdain for the status quoAbility to thrive in a fast-paced and dynamic early-stage company work environmentCompany OverviewImproving patients' lives by facilitating high quality clinical research through a collaborative network of physicians. It was founded in undefined, and is headquartered in Birmingham, Birmingham, GBR, with a workforce of 11-50 employees. Its website is https://www.hrcrs.com.