- 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. Any other European language would be beneficial
- Relevant experience in clinical research and/or clinical site management (optional if promotion within the company) à to be removed as denoted/required by local HR and regulations
- Previous experience in people management is desirable
- Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
- 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.
- Knowledge in the use of MS Office, Clinical Database (preferably Oracle)
- Ensure the execution of clinical studies in assigned studies as a specific site and territory owner
- Develop and maintain a productive clinical territory
- Supervise all aspects of study lifecycle to include site regulatory and quality including SIV and monitoring reporting supervision
- Guarantee ability of the team to provide training and enrollment/procedure/f-up coverage where required
- Identify and adapt to shifting priorities and competing demands across the area and projects
- 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
- Monitors 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 expert 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.
- Use critical thinking to identify issues, address them, and create plans to augment success or prevent recurrence.
- 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 (drive development of CAPAs as needed and identified).
- 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)
- 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
- Takes responsibility and mentorship to support onboarding activities and support of clinical site management team members
- Take responsibility as EMEA protocol champion for assigned studies:
- Proactively, and with minimal guidance, look for ways to facilitate strong performance and capabilities of study sites within their region.
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Clinical Territory Manager - Solihull, United Kingdom - Abbott Laboratories
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.
Purpose of the role
The Clinical Territory Manager (CTM) supervises 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.
Minimum Requirements
Responsibilities
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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