**About Abbott** At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, we serve people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. Our 115,000 colleagues are helping millions of people to live better and healthier, every day around the world. Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: + Career development with an international company where you can grow the career you dream of. + A company named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** The Clinical Site Lead (CSL) drives study execution, operational excellence and site management across Abbott therapies and Business Units as per local and international regulations and abiding by Abbott’s procedures. Recognized subject matter expert in clinical Working Instructions, Clinical Investigation Plans and product/disease state throughout the lifecycle of the study: startup, enrollment, compliance and follow up, data quality, monitoring and study/site closeout. **What You´ll Do** + Act as the main point of contact internally and externally for study sites + Coordinate, implement, execute and support clinical studies within assigned country/region + Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality. + Identify appropriate investigators as defined by study-specific requirements + Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution as per working instructions + Facilitate all aspects of the start-up process in coordination with Site Operations team and lead activities to ensure site activation and project enrollments within timelines and defined forecasts + Develop site-specific strategies to promote appropriate patient enrollment. + Identify site successes and challenges and assist in implementing techniques that promote study goal achievement. + Attend study procedures and follow-ups when indicated per study specific requirements + Monitor clinical studies at sites to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. + Should achieve Core level Abbott certification and/or equivalent level proficiency. + Review data and source documentation from investigational sites for accuracy and completeness + Continuously evaluate site study performance and provide timely feedback to site. + Lead, initiate, coordinate and/or perform activities to ensure clinical study and regulatory compliance on site and as indicated, per Key Compliance Indicator and supports audits as applicable. + Ensure adverse events, device complaints and protocol deviations are reported in an efficient and timely manner per regulations and Abbott procedures + Resolve and/or facilitate resolution of identified issues including identification of cause and actions to prevent reoccurrence. + Promptly reports the findings of monitoring visits as per timelines and standards identified in working instructions + Collaborate with Site Operations teams to ensure complete submission of study and filing of site and study documents + Train and retrain site personnel to ensure compliance with the study protocol and local regulations, as required or needed + Check project products availability and traceability (if applicable) + Communicate internally on project progress to stakeholders + Contribute to site budget discussions and provide field perspective. Coordination with contracts associates on contract execution. + Provide continuous updates and follow up on studies and sites to Clinical Operations and Study Management + Be the point of contact for discussions, collaboration and updates with local/regional commercial teams **Required Qualifications** + Background in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research. + Fluency in English (both written and verbal) and local/country. Portuguese language is an asset + Knowledge in the use of MS Office, Clinical Database (preferably Oracle) + At least 2 years of relevant experience in clinical research and/or clinical site management **Preferred Qualifications** + Communication, prioritization, organizational and time management skills + Team player with positive constructive attitude + Strong self-development abilities and able to work independently + Proficient knowledge of medical terminology. + Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). + Expertise in study conduct, follow up and monitoring + Advanced knowledge of clinical and outcomes research study design. + Experience working in a broader enterprise/cross-division business unit model preferred. + Ability to work in a highly matrixed and diverse business environment. + Ability to work within a team and as an individual contributor in a fast-paced, changing environment. + Multitasks, prioritizes and meets deadlines in timely manner. + Ability to travel at least 70%, including internationally. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com