Descripción de la oferta
Clinical Site Lead (EMEA) Role Summary The Clinical Site Lead drives study execution, operational excellence, and site management across multiple therapy areas in accordance with local and international regulations. This role is a recognized subject matter expert in clinical working instructions, clinical investigation plans, and product/disease state throughout the full study lifecycle, from startup through closeout. Key Responsibilities Acts as the primary point of contact, internally and externally, for assigned study sites. Coordinates, implements, and executes clinical studies within assigned country/region. Identifies, develops, and maintains sites capable of delivering startup goals, study participation levels, and required data quality. Identifies appropriate investigators, completes qualification processes, and establishes site/sponsor expectations for study execution. Facilitates all aspects of the site startup process, coordinating with Site Operations teams to ensure activation and enrollment within timelines. Develops site-specific strategies to promote appropriate patient enrollment. Attends study procedures and follow-ups as required per study-specific requirements. Monitors clinical studies at sites to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards, including initiation, periodic, and closeout visits. Reviews data and source documentation from investigational sites for accuracy and completeness; provides timely feedback to sites. Leads, initiates, and coordinates activities to ensure clinical study and regulatory compliance, including Key Compliance Indicator reporting and audit support. Ensures adverse events, device complaints, and protocol deviations are reported in a timely manner per regulations and standard procedures. Resolves and/or facilitates resolution of site issues, including root cause analysis and preventive actions; reports monitoring visit findings per required timelines. Trains and retrains site personnel to ensure compliance with the study protocol and local regulations. Provides continuous updates on study and site progress to Clinical Operations and Study Management. Contributes to site budget discussions and coordinates with contracts associates on contract execution. Required Qualifications Background in engineering, science, health science, nursing, or a related field; or equivalent experience in cardiology or clinical research. Minimum 4 years of relevant experience in clinical research and/or clinical site management. Fluency in English (written and verbal) and local/country language. Proficiency in MS Office and clinical database systems (Oracle preferred). Expert knowledge of GCPs and regulatory compliance guidelines for clinical trials (applicable ISO standards, FDA regulations). Expert knowledge of clinical study conduct, follow-up, and monitoring. Advanced knowledge of clinical and outcomes research study design. Strong communication, prioritization, organizational, and time management skills. Proficient knowledge of medical terminology. Ability to work independently and within a team in a fast-paced, matrixed environment. Ability to travel at least 70%, including internationally. Preferred Qualifications Additional European language skills. Experience working in a cross-division or enterprise business unit model. Terms & Start 12+ month contract Remote - travel to clinical sites within region
