JOB DESCRIPTION: We are currently recruiting for a Clinical Lead to ideally be based within the London area. There will be a 75 % travel requirement across the UK and Northern Ireland for this role. Reporting into the Director - Clinical Site Management, we are looking for individuals with a strong clinical background ideally in medical devices and cardiology. Duties & Responsibilities · 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 Minimum Requirements · Relevant experience in clinical research and/or clinical site management. · Related experience in cardiology or clinical research or medical devices. · Expertise in study conduct, follow up and monitoring · Fluency in English (both written and verbal) and local/country. Any other European language is an asset · Proficient knowledge of medical terminology. · Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). · Communication, prioritization, organizational and time management skills · Team player with positive constructive attitude · 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. As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Clinical Affairs / Statistics DIVISION: MD Medical Devices LOCATION: United Kingdom : Blythe Valley Park, Elder (Plot C1b), Central Boulevard Solihull ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 75 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Driving a personal auto or company car or truck, or a powered piece of material handling equipment