AdresseSection 1: PURPOSE OF THE JOB
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.
Section 2:ROLES & RESPONSIBILITIES
Ensure the execution of clinical studies in assigned studies as a specific site owner:
- 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
Section 3: EDUCATION & COMPETENCIES
- 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 French.
- Knowledge in the use of MS Office, Clinical Database (preferably Oracle)
- At least a relevant experience in clinical research and/or Clinical Site management
