Clinical Site Lead - Solihull, United Kingdom - Abbott Laboratories

Abbott Laboratories

Verified Company

Solihull, United Kingdom

4 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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 startup goals, study participation levels and required data quality.
Identify appropriate investigators as defined by studyspecific requirements
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution as per working instructions
Facilitate all aspects of the startup process in coordination with Site Operations team and lead activities to ensure site activation and project enrollments within timelines and defined forecasts
Develop sitespecific 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 followups 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 closeout 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/crossdivision 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 fastpaced, 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.