Clinical Site Lead ( ideally based in London)

Job description

JOB 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 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.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Clinical Affairs / Statistics

     

DIVISION:

MD Medical Devices

        

LOCATION:

United Kingdom : Blythe Valley Park , Elder (Plot C1b), Central Boulevard Solihull

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 75 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Driving a personal auto or company car or truck, or a powered piece of material handling equipment