Clinical Site Lead

1 month 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 youâd 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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