Clinical Site Lead

2 months ago

Solihull, United Kingdom Abbott Laboratories Full time

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.

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