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
Qualifications
* 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
Benefits
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.
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